Alnylam Pharmaceuticals, a Cambridge, MA-based developer of RNA-interference drugs, said today that it sees a new business opportunity in using its gene-silencing technology to increase the output of biomanufacturing processes. The company, which has already successfully licensed its RNAi technology for drugs, is looking to make additional money from its science by licensing it for manufacturing many types of biotech drugs.

The company (NASDAQ:ALNY) is presenting data today at its R&D day in New York that support the use of RNAi to silence certain genes in Chinese hamster ovary cells, which are used in biomanufacturing. Alnylam’s data show that the RNAi technology improved the viability of the cells by 40 to 60 percent, compared with untreated cells. The firm used RNAi to switch off certain genes that control metabolism in the cells, as well as genes involved in a cellular self-destruct mechanism.

An internal group at the company called Alnylam Biotherapeutics is advancing the application of RNAi technology in biomanufacturing. The firm, which plans to retain ownership of this use of the technology, says it could improve the production of existing biotech drugs, new biologics, and copies of biological treatments, known as “biosimilars” or “biogenerics.”

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Synageva BioPharma, a Waltham, MA-based developer of new and generic biotech drugs, said this morning that it has raised $12 million, on top of $33 million announced in May, to complete a $45 million round of financing. The round included previous investors as well as a new investor, New Leaf Venture Partners, of New York and Menlo Park, CA. Srini Akkaraju, a managing director at New Leaf, is joining the board of directors at Synageva in connection with his firm’s investment in the company.

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Ryan and Luke did a couple of great in-depth stories this week—on the burgeoning business of biogenerics and on a young company out to take on the big boys of cancer with a new mouse model for the disease.

—Ryan took a look at the Boston-area biotech companies that are poised to become key players in the nascent field of biogenerics (aka biosimilars, follow-on biologics, or copycat biotech drugs). Cambridge, MA-based biotech powerhouse Biogen Idec (NASDAQ:BIIB), for instance, has established a Swiss subsidiary called Eidetica Biopharma to get in on the action, while Merck & Co.’s Lebanon, NH-based GlycoFi unit offers technology that could help overcome some of the technical challenges of making copies of biotech drugs. And Cambridge-based Momenta Pharmaceuticals (NASDAQ:MNTA) and Waltham, MA-based Synageva BioPharma are both working on a mix of novel and biogeneric drugs.

—Natick, MA-based Boston Scientific (NYSE: BSX) announced that its longtime president and CEO, Jim Tobin, is retiring. Ray Elliott, previously the chairman, president, and CEO of Warsaw, IN-based Zimmer Holdings (NYSE: ZMH), will take the helm of Boston Scientific.

—Luke got an update from Aveo Pharmaceuticals CEO Tuan Ha-Ngoc about his Cambridge, MA-based company’s progress in turning a novel mouse model for cancer into a thriving, sustainable company. Aveo’s lead drug candidate, a treatment for kidney cancer, produced promising results in a clinical trial unveiled in May.

—A tenth patient taking Cambridge, MA-based Biogen Idec’s (NASDAQ:BIIB) Tysabri has contracted the rare brain infection PML. Tysabri is approved for the treatment of multiple sclerosis and Crohn’s disease.

—IntelligentMDx raised $3 million from a group of unnamed, non-venture investors, bringing the total raised by the Cambridge, MA-based startup to $26.5 million. IntelligentMDx is developing DNA- and RNA-based medical tests.

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Boston-area biotech companies have kept a close eye on how U.S. regulators decide to govern the approval of copycat versions of biotech drugs. Now I’m seeing more signs that some of these companies could actually become major players in the business of making biogenerics (which are also called biosimilars, follow-on biologics, and other names, depending who you’re taking to.)

Cambridge, MA-based Biogen Idec (NASDAQ:BIIB), for starters, has very quietly established a subsidiary called Eidetica Biopharma to develop and manufacture what Biogen calls biosimilars, according to unnamed sources with knowledge of the subsidiary. There’s scant information available on Zug, Switzerland-based Eidetica, but it’s clear that this firm is a sign that Biogen is looking to get a piece of the biogenerics pie.

Biogen is just one of several examples, though, of life sciences companies that are taking an interest in biogenerics as a potential revenue stream. Many already have the infrastructures and the internal brainpower to produce original biotech or biologic drugs. And a barrier to entering the business of making biogenerics is the huge investment required to build biotech drug plants, which must also be approved by regulators before the facilities can market products manufactured there. There are also businesses, such as Merck & Co.’s GlycoFi, of Lebanon, NH, where innovative technology has overcome some of the technical challenges of making copies of biotech drugs.

Scientia Advisors, a life sciences consulting firm in Cambridge, MA, has fielded a lot of inquiries lately from companies in the Boston area and elsewhere about the viability of the biogenerics market, Amit Agarwal, a partner at Scientia, tells me. He says the interested parties include all companies with the facilities to produce biologics. “What we’re seeing is that they are at least considering this market,” Agarwal says. “It’s out there and it’s not just coming from the usual suspects.”

The future of the biogenerics market, at least in the U.S., is very much up in the air at the moment. Biogenerics have been near the top of the biotech industry’s policy agenda for years, but the issue has heated up recently as U.S. lawmakers look to overhaul the healthcare system. There are biotech companies that fear an invasion of biogeneric drugs into the marketplace could hurt their sales, as well as their ability to fund the development of novel biotech drugs. But some lawmakers see the approval of these copycat treatments as important to controlling the rising cost of drugs. And at the center of the current biogeneric debate is how to formulate a regulatory pathway to approve these drugs.

Some of the key issues in the biogenerics debate are related to the inherent differences between biologics and small-molecule, chemical drugs. Biologics, typically made in processes that involve living cells and bioreactors, are often protein-based drugs with complex structures that cannot be duplicated like their small-molecule brethren. This means that biogeneric drugs aren’t exact copies of the originals, creating all manner of questions about whether the knockoffs should be required to undergo additional clinical trials to prove their safety and effectiveness. As I mentioned, there are local firms that have entered this market because they believe than can overcome some of the technical obstacles.

GlycoFi, for instance, has recombinant yeast technology that enables it to have greater control over the molecular form of protein-based drugs than is otherwise possible. Merck, which purchased GlycoFi for $400 million in 2006, is using this science as the technical backbone of its recently launched biogenerics business unit, Merck Bioventures. Here’s our recent story about the leading role that GlycoFi is playing in the biogenerics unit. In fact, Merck has even begun to call its copycat biotech drugs “bio-betters,” because it believes it can engineer the proteins to be better than the originals. (Henri Termeer, the chairman and CEO of Cambridge, MA-based biotech powerhouse Genzyme (NASDAQ:GENZ), poked fun at the bio-betters moniker during a recent interview, an audio recording of which is embedded in this post from last week.)

Indeed, Cambridge-based Momenta Pharmaceuticals’ (NASDAQ:MNTA) …Next Page »

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I’m always hesitant to try to read the tea leaves on the future of biogenerics—those would-be lower-cost copies of protein-based biotech drugs. After all, the question of if, when, and how the FDA would create a mechanism for approving such drugs has been kicking around, unanswered, for almost as long as I’ve been covering biotech. But I’ve got to say the news yesterday that the FDA had rejected a request from Cambridge, MA’s Genzyme (NASDAQ: GENZ) for clearance to sell batches of one of its own already approved drugs, made at a different plant from the one that produced the drug for the original approval—well, that doesn’t look so good, for Genzyme or for biogenerics.

Genzyme has been trying to scale up production of the drug Myozyme, which was approved in 2006 for the treatment of an inherited muscle disorder called Pompe disease. The drug is already produced for the U.S. market at the company’s Framingham, MA, plant, but to meet demand Genzyme started churning it out on a much larger scale at a plant in Boston. Yesterday, the company said it had been informed by the FDA that the agency considered the Myozyme coming out of the Boston plant to be a new product, rather than more of the same stuff that’s already been approved, and that Genzyme would need to file a new application for the Boston-made Myozyme if it wants to sell it on the U.S. market. (Genzyme pointed out in its press release about the agency’s decision that marketing the Boston batches of the drug has already been approved in 40 other countries.)

One of the central arguments against allowing generics makers to produce copies of biotech drugs once the patents expire is that, since such drugs are made by living cells rather than precise chemistry, they’re very sensitive to tiny changes in the manufacturing process. Allowing another company to produce the drug, opponents of biogenerics warn, would be likely to result in a product that was not exactly the same as the original, and not necessarily as safe or effective as the original. Many observers have pointed to the Myozyme example as powerful support for this argument—here you have the same company making the same drug at different plants, and the products don’t come out identical. (I took a look at some of the arguments on both sides of this debate last summer, when Genzyme’s troubles with scaling up Myozyme production first came to light.)

As competing pieces of biogenerics legislation have inched their way through Congress, a critical question has been whether the FDA will ultimately require generics manufacturers to perform new clinical trials to get copycat protein drugs on the market. (One of the main reasons that makers of traditional generics can sell drugs more cheaply is that they are spared the huge expense of clinical trials.) If Myozyme is really a magic eight ball, signs point to ‘yes.’ To sell the Boston-made drug, Genzyme will have to submit more clinical-trial results. Luckily for the firm, the agency seems to be willing to accept data from a study that Genzyme had already undertaken to fulfill a post-marketing requirement.

All in all, Genzyme expects that the FDA’s latest action will push the U.S. commercial availability of Boston-made Myozyme back until the first quarter of next year. The company knocked $45 million off its 2008 sales projections for the drug and $0.10 off its 2008 per-share earnings projections. Shares of Genzyme opened today at $72.29, down 2.4 percent from yesterday’s close of $74.09.

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As a rule, getting a drug on the market turns a biotech startup from a buck bonfire into a cash cow—or at least a cash calf. But rules tend to get broken. Just ask GTC Biotherapeutics. In mid-2006, European drug regulators approved the Framingham, MA-based company’s first medicine, ATryn, a protein for blocking risky blood clots. Trumpets blared: It was the first drug made in bioengineered animals—genetically altered goats on GTC’s famed “pharm” near Charlton, MA, produce the medicine, a human blood protein called antithrombin, in their milk. Pharming’s longstanding promise—the ability to churn out large quantities of protein drugs at relatively low cost—was finally a commercial reality.

But despite making history, GTC was soon pegged by investors as little more than a cash embryo. ATryn, which GTC had licensed to Denmark’s LEO Pharma, was approved to prevent blood clots in patients with a rare, inherited antithrombin deficiency who were undergoing surgery. Annual sales, perhaps only a few tens of millions of dollars, wouldn’t come close to making GTC profitable. Last year the company’s shares drifted under a dollar each, prompting the NASDAQ Stock Market to notify GTC in January that its stock was headed for delisting. Last Friday the company underscored its cash-strapped status by announcing that it had agreed to sell 6.9 million shares to institutional investors at a fire-sale price of 87 cents a piece. Following the announcement, its share price fell below 80 cents.

You’d think all this would get CEO Geoffrey F. Cox’s goat. But when I talked to him last week, he sounded upbeat, reeling off a number of reasons GTC’s stock price isn’t likely to linger in the sub-buck-a-share danger zone for delisting.

First, he noted, GTC is in talks with a “number of parties” interested in partnering with it to commercialize ATryn in the U.S. (GTC said earlier that it hoped to complete the deal by the end of this quarter). “It’s very tough to predict with certainty” that that timing goal will be met, Cox added. “Nothing’s gone wrong—the negotiations are going very well. But these things take time, and I’m anxious to do the right deal rather than do one just to meet a timeline.” GTC’s negotiating position just got a bit stronger—it recently racked up key clinical data for ATryn’s U.S. approval.

A partnership would add sorely needed funds to GTC’s coffers. As of September 30, the company had only about $21.8 million in cash, less than its net loss of $26.5 million for the first nine months of 2007. (The latest stock sale announced Friday brought in some $6 million.) It would also put ATryn on the road to correcting antithrombin deficiencies much more prevalent than the rare, inherited one it’s approved to treat.

One such deficiency sometimes occurs in patients undergoing coronary artery bypass surgeries—potentially a $150 million to $200 million-a-year market, according to Cox. Another is disseminated intravascular coagulation, or DIC, which can cause deadly blood clots in patients with severe infections, an indication GTC sees as potentially a multi-billion-dollar market. LEO Pharma, GTC’s European partner, is conducting a Phase 2 trial with ATryn for DIC patients. “Hopefully LEO will complete patient recruitment over the next year or so,” Cox said. The trial might be followed by a large, international Phase 3 study sponsored by LEO and GTC’s to-be-announced U.S. partner, speeding ATryn’s approval for DIC in both Europe and the U.S..

GTC also plans to produce a protein called factor VIIa, used to treat hemophilia. Currently extracted …Next Page »

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A drug company is never happy to get a “not approvable” letter from the FDA, and the one received Monday by Cambridge, MA’s Momenta Pharmaceuticals (NASDAQ MNTA) and its partner Sandoz was a doozy, coming more than two years after the firms filed for approval of a generic version of Lovenox, which had U.S. sales of $1.9 billion in 2006. But my first thought when I heard the news was, wow, the biogenerics people are going to be bummed.

The debate over biogenerics—generic versions of biotech drugs or “biologics”—is a complicated one. To get a generic version of a traditional drug approved, a manufacturer must show, essentially, that its product is chemically equivalent to the original. But guidelines that would spell out exactly what biogenerics manufacturers need to do to get their products approved have been repeatedly delayed. Opponents of biogenerics often argue that biologics—typically proteins made by genetically engineered cells, as opposed to traditional small-molecule drugs that are synthesized in a chemistry lab—are inherently too complex to be copied exactly, or even characterized completely. So approving a biogeneric, the argument goes, should require that the manufacturer conduct new clinical trials. But such trials are extremely costly; indeed, traditional generics makers can afford to offer low-cost drugs precisely because they don’t have to pay for the trials.

Momenta was founded in 2001 around technologies developed at MIT that allow for unprecedented analysis of the complex sugars that are attached to proteins during their manufacture in the cell—sugars which can profoundly affect what a protein does to the body when you inject it as a drug. The company entered the biogenerics fray on the argument that if you can completely map those sugars (along with the protein backbone, which is an easier proposition), you can in fact prove that a new drug is identical to an old one—without expensive clinical trials.

I have to admit that I’ve always found that to be a pretty compelling argument, so when I saw the words “Momenta,” “generic,” and “rejected,” in the headlines, I made the connection to bad news for biogenerics. A few other bloggers did too, evidently—ones I really admire and to whom I’m not going to link because, in this case, I think we were all wrong.

The first problem is that, though Momenta does have generic versions of biologics in its pipeline, Lovenox itself (a blood-thinner made by Sanofi-Aventis) is not a biologic. What it is is a complicated type of carbohydrate—which is where Momenta’s sugar technology comes in—derived from pig intestines. As such, the drug occupies a strange netherworld between traditional drugs and biologics. And since few drugs fall into that category, the ramifications of the FDA’s rejection of this one—and the fact that it looks like the agency might wind up requiring Momenta to conduct clinical trails of the drug if it’s to ever be approved—are limited.

Okay, but I was thinking this rejection might still bode ill for the FDA ever accepting Momenta-style analysis as a substitute for clinical trials in the approval of true biogenerics. The problem with that line of reasoning, my sources say, is that we’re just too far away from having any guidelines for approval of such drugs to even hazard a guess at what the agency might require. And with a change in the administration looming, it’s likely to take several years before guidelines are in place.

And the last way in which my initial reaction was wrong? Well, I get the impression that there aren’t that many “biogenerics people” around right now to be bummed. I don’t know if it was just bad luck, but everybody I called—folks who have in the past been very tuned in to the debate—seemed to feel that with guidelines so far off, there’s little one can say or do about biogenerics at this moment. In other words, the rejection of the Momenta drug can’t mark a setback for biogenerics because biogenerics aren’t getting anywhere in the first place.

Of course, I could be wrong.

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It was a sunny, steamy morning last week when I elevatored upstairs at Biogen Idec’s Kendall Square headquarters to interview CEO James Mullen—and I sat right down in the hot seat.

Literally. Mullen awaited in a big-windowed conference room; I perched with my back to the sun and instantly started baking. Mullen smiled. Did the CEO enjoying seeing a reporter sweat? Nah, couldn’t be. He quickly lowered the shades, and we got down to business.

Biogen is on a nice little roll. It just reported a big jump in second-quarter income and profits. An FDA advisory panel recently recommended that its multiple sclerosis drug Tysabri, co-developed with Elan, be approved for treating Crohn’s disease. This news, coupled with Biogen’s buyback of about $3 billion worth of its shares in early July, has the company’s stock (NASDAQ: BIIB) trading at right around $59 a share, flirting with a two-year high.

That’s the good news. The not-so-good news is that Biogen, like every major biotech firm (and big Pharma as well) these days, has pipeline concerns. Also like other firms, Biogen has some serious policy headaches to deal with right now—patent reform and generic biotech drugs chief among them (more on these later).

All of which means that Mullen had a lot to say. Because we covered so much ground, I’m going to break this into two parts. Today I’ll explore Mullen’s take on the biotech industry, its evolution, and its future. Tomorrow’s story will examine Biogen’s multi-tiered strategy for managing innovation. Here’s a hint: “Luck,” he quips, “is not part of the strategic plan.”

But that’s for tomorrow. Today, let’s start with Mullen’s version of Biotech 101.

The 1960s saw “a huge explosion of innovation in Pharma,” Mullen says, and that expansion lasted close to 30 years. Beginning in the late 70s and early 80s, as he puts it, “biotech pokes its nose up out of the ground.” The upstart field gets traction in the early to mid-80s, and the first important products (think Genentech’s recombinant human growth hormone, Protropin, or Amgen’s antianemia treatment Epogen) arrive soon thereafter.

The 90s brought the genome sequencing wars. Many people miss the true importance of that, Mullen says. “Probably the more important thing, more important than the human genome, was all the technology developed around it—which allowed the inquisition of biology in a way that had never been done before,” he says.

“So, for biotechnology, we’re in this interesting place,” says Mullen. “If you look for 30 years cumulatively, we’ve not made money as an industry. There are some spectacular successes, and there’s a huge amount of value that’s been created with the technology.” But true, sustained, profit-making? Not there.

That, says Mullen, is about to change. “We are catching up to where the Pharmas were maybe 20 years ago,” he says, adding, “The discoveries and developments over the next 20 years will be stunning.” He then rattles off a litany of fields such as human drugs, animal pharmaceuticals, agricultural products, and energy (such as corn to ethanol), where biotech will be making ever-greater contributions.

Mullen’s predictions echo those made at the birth of the industry—including in Biogen’s original business plan back in 1978, he points out. The company housed its research headquarters in a two-story brick building that also served as a manufacturing plant. There, Biogen kept bins full of corn stover (the leaves and stalks left over after corn is harvested), from which it sought to make ethanol—an idea that proved a bit ahead of its time. “Not sure anybody did the math too carefully on that back then,” Mullen says.

If Biogen was in the dark about the true costs of making fuel from corn, it was equally short on knowledge about regulatory procedures, management of manufacturing processes, and other critical issues needed to run a world-class business. When Mullen arrived in 1989, he says, there was so much to do to bring Biogen up to the standards practiced by big Pharma “that you almost didn’t know where to start.”

Those days are, of course, long gone. Biotech firms now have to be incredibly sophisticated, particularly in Washington, where debates are raging over patent reform, the pricing of drugs, user fees, generics, and more. Government and legislation are always issues, says Mullen. “What’s unusual is that a number of these issues have all come to a boiling point all at the same time.”

Here’s Mullen’s take on the big two, patent reform and biogenerics.

Patent reform
At the heart of the issue is a patent-reform bill, currently making its way through Congressional committees and well-described in the Boston Globe, that many see as favoring the interests of the software industry over those of biotech, in part by limiting damages in patent-infringement cases. “Given the short product cycles in the software industry, it’s understandable that they’d want those changes. But the changes would have unintended and negative consequences for discovering and developing new cures and treatments for patients,” Mullen says. “If patent reform lowers the bar—by weakening the penalties—for competitors to infringe upon a valid patent, investors will not finance the lengthy and expensive development of biotech products.”

That, of course, is the biotech line, and there’s plenty of room for disagreement. To his credit, Mullen doesn’t see the issue as cut-and-dried. “I’m more of a pragmatist on that,” he says. “I think that they’ve got some legitimate issues that have to be sorted through. Personally I think we missed the really central point, which is having a highly functioning Patent and Trade Office.” He favors giving the office more resources to do its job.

Biogenerics
To what degree should generic drugmakers be allowed to put out versions of biotech drugs—and what regulatory hoops should they have to jump through to do so? Here’s a piece Mullen wrote last April for the Wall Street Journal that partly deals with this complicated issue.

With bills aimed at creating a pathway for biogenerics currently wending their way through the House and Senate, Mullen wants the government to think this issue through very carefully before acting. “We have long supported the creation of a pathway for follow-on biologics,” he says, using a term for biogenerics preferred by many industry insiders. However, he believes that such a pathway must recognize “that biologics are vastly more complex” than the small molecule drugs typically made by big Pharma.

Mullen is particularly concerned about data exclusivity. This term refers to the period of time would-be generics makers are prevented from using the original firm’s safety and effectiveness data as evidence supporting approval of a knockoff drug. Like BIO (the Biotechnology Industry Organization), Mullen wants 14 years of data exclusivity, instead of the five years enjoyed by makers of small-molecule drugs. You can dive deeper into this issue here. BIO’s core argument is that such an added safeguard is necessary because patent protection is inherently weaker for biotech drugs than for small-molecule drugs, and that a longer period of data exclusivity will help level the playing field. “If we think we’re the knowledge economy and the innovation economy, that only works if there’s a way to protect the innovation,” Mullen says.

While the patent reform and generics debates play out in Washington, there’s one more big issue facing biotech companies that we barely touched on in our interview—the convergence of biotech and Big Pharma. In the past, large drugmakers have made small-molecule drugs, whereas biotech firms have produced protein-based drugs. Now, in the hunt to keep pipelines full, the two are converging.

“So there are all these questions,” Mullen says. “What’s the consolidation? Should Pharma be buying biotech? Or are they the dinosaurs?”

More tomorrow on Mullen’s plans to make sure Biogen itself doesn’t become a dinosaur.

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The last couple of days have seen a flurry of blogging about biogenerics (or biosimilars or follow-on biologics, depending on your take on the issue), prompted in part by a Wall Street Journal article about Genzyme’s troubles scaling up production for a recently approved enzyme drug.

Myozyme, approved by the FDA last year for the treatment of an inherited muscle disorder called Pompe disease, could be a big source of revenue for Genzyme—the drug can cost more than $300,000 per year for an adult patient, according to the Journal article. But Genzyme has been unable to scale up production of the drug because the FDA has so far declined to approve a Boston plant meant to be its main source. While the company waits for that approval, it is providing some U.S. patients with free doses from a different plant in Framingham, MA—the one that produced the drug for the clinical trials—on an experimental basis. (The Framingham product is already approved for sale in other countries, but not the U.S.)

What’s stalling approval of the new factory, according the article, is a chemical difference between the Myozyme produced in Framingham and that produced in Boston. “Making biologics is complicated work, and that’s one reason the biotech industry has voiced caution about legislation to allow generic versions of the medicines,” writes the Journal’s David Armstrong in a blog post following up on the Myozyme article, which he co-authored. “In the case of Myozyme, billions of cells from hamster ovaries growing in large stainless steel tanks produce the enzyme Pompe patients lack. The fact that Genzyme, which has loads of biotech experience, is having such difficulty ramping up production of its own drug heightens worries about the ability of generic manufacturers to accurately copy brand-name biotech drugs,” he adds.

VentureBeat’s David Hamilton picked up the thread today—and took issue with Armstrong’s take on the Myozyme example. He writes that “the biotech industry wants to have it both ways when it comes to the ‘complicated work’ of making biologics. Where biogenerics are concerned, the industry insists that copycat versions of biotech drugs must undergo those expensive and lengthy clinical trials in the interests of ‘patient safety.’ When it comes to their own drugs, however, biotech companies are perfectly willing to rely on a battery of simpler tests to ensure that a new production batch is equivalent to an old one.”

Meanwhile, Melanie Senior at the IN VIVO Blog questions the market for biogenerics by looking at the example of Omnitrope, which she characterizes as “the first biosimilar drug approved in Europe and the only one available on both sides of the Atlantic.” (For a nice illustration of just how contentious this field is, check out the FDA’s Q&A on Omnitrope, which refutes the commonly held idea that the drug is a generic biologic.) Senior writes that despite the fact that Omnitrope sells at a discount of 20 to 30 percent over the innovator drug, “education and perception are blocking widespread uptake.” Based on her interview with Ajaz Hussain, vice president and Global Head of Biopharmaceutical Development at Sandoz, Omnitrope’s manufacturer, Senior writes: “Sandoz reckons it needs more competition to help it drive wider acceptance and trust of biosimilars among prescribers, but not too much so as to render the economics of the game impossible.”

All interesting stuff, and sure to evolve over the weekend. We’ll keep an eye on it.

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