Amgen Discusses Biosimilars Strategy
Apr22

Amgen Discusses Biosimilars Strategy

Yesterday, Amgen held its first business strategy meeting since the fall 2008, and mixed in with much talk of its bone-loss treatment denosumab was a discussion of its strategy around biosimilars. The company gave its view of the impact of generic versions of its biologic drugs in Europe and the U.S., as well as the opportunity for its own growth in the space. Several core drugs in the Amgen portfolio will be under pressure from biosimilars after 2015, but management downplayed the impact the competition would have on its business. Because of their complexity, biosimilars aren’t subject to the same “patent cliff” small molecules face when their patent expires, Amgen’s CEO Kevin Sharer said. And although the company expects biosimilars to exist in the U.S., and for prices to be impacted, “we do not expect revenues to go away overnight,” he added. Although U.S. regulatory authorities have yet to sort out a pathway for approving biosimilars, generic entrants have already made their way into European markets. Biosimilars have taken over about 6% of the market for Amgen’s anemia treatment Aranesp, and pricing has been “pretty disciplined” after their first few months on the market, noted Amgen’s president and chief operating officer Robert A. Bradway. European market share for biosimilar competitors to Amgen’s filgrastim franchise, which includes the multi-million dollar seller Neulasta, has also stayed steady at around 6%. At the same time, Sharer cautioned that things will not play out identically to the U.S. and Europe. Further, he reminded the audience that “there is no such place as Europe—that’s some figment of a travel agent’s imagination." The experience across countries has not been uniform, and generic erosion has occurred much faster in some countries than others. Still, looking back to Amgen’s expectations for the impact of biosimilars had been far bleaker than what has occurred so far in Europe. “Frankly, if we’d beeen sitting here inside an Amgen meeting five years ago…we’d have anticipated a different outcome” regarding biosimilars, Sharer added. Amgen’s chief also pointed out that because Amgen has such broad experience in developing and manufacturing large molecules, there could be a significant upside as the company starts to compete in the biosimilars arena. The business won’t immediately skyrocket after 2015, “but in the several years after that, it has multi-billion dollar potential for us,” he said. The company has created a small biosimilars unit, and Sharer says that in talking with partners it appears that establishing a presence in the arena “will not require much investment on our...

Read More
Merck’s Kamarck Talks Biosimilars
Jul02

Merck’s Kamarck Talks Biosimilars

Reuters has a report out today on the potential market for biosimilars, or generic versions of biologic drugs. The players will be few, and the challenges many, the report suggested. “Access to the nascent market for so-called biosimilars, worth an estimated $10 billion (6.6 billion pounds) by 2015, will be limited to a close circle of specialist companies with the means to invest heavily and to fend off a legal onslaught, analysts said.” Coincidentally, I sat down earlier this week with Michael Kamarck, the new head of the company’s biosimilars arm Merck Bioventures. Kamarck, who previously headed up biologics manufacturing at Wyeth, had a strikingly similar perspective on the market. He also expects few players based on a high barrier to entry. Biosimilars players will need to have technology capabilities (see Genzyme’s woes for the challenges of manufacturing biologic products), the financial mettle to conduct large clinical trials, the ability to navigate a still fuzzy regulatory pathway, and the right commercial strategy once a biosimilar is approved. When asked about drug pricing, Kamarck noted that in markets with a limited number of players, prices tend to stabilize after an initial drop. The biosimilars approved in Europe generally cost about 70% of the innovator’s price, and he expects the U.S. market will shake out in a similar way. “We think that’s a good model and provides a fair return and a large advantage for patients,” he said. Why so little of a discount? As the Reuters article explains, the “development, production and marketing of a copycat version of biological drugs already cost about 50 times the amount needed to launch a generic copy of conventional chemical drugs.” However, biosimilars players could have an advantage of more cost-effective manufacturing. When asked whether he was worried about innovators simply lowering their price or selling their own biosimilars, a strategy Amgen seems prepared to pursue, Kamarck pointed to the significant improvements in yields of the mammalian cell culture lines used to make many top-selling biologics. The innovator, on the other hand, has to go through FDA to make changes to their manufacturing process. “It might well be that coming into the game now, you can make manufacturing improvements to the processes that the innovator is stuck with,” he adds. Merck has two biosimilars, both acquired last year from Insmed, in the clinic: MK-4214 and MK-6302, generic versions of Amgen’s Neupogen and Neulasta, respectively. The company plans to  have five biosimilars in late development n 2012, though isn’t identifying which innovator medicines they will be copying. Development of MK-2578, a similar version of Amgen’s Aranesp, was abandoned earlier this year due to regulatory and...

Read More
Beyond siRNA: Alnylam’s Other Biotherapeutics Ambitions
Apr28

Beyond siRNA: Alnylam’s Other Biotherapeutics Ambitions

Alnylam gave a first peek today inside its new biotherapeutics manufacturing business, launched in November. So far, it looks kind of intriguing. Though best known for as a leader in the race to turn siRNA into viable therapeutics, the company has embarked on a bit of a side project: using siRNA to improve the yield of biologics manufacturing process. As you’ve probably read, therapeutic proteins such as monoclonal antibodies ain’t cheap. And though it’s safe to assume the mark-up on biologic drugs like Genentech’s Avastin is high, they also are quite expensive to produce. One major issue has been the low yield of those infamous Chinese hamster ovary cells churning out some of our antibody therapeutics—they don’t live long and not everyone in the pot likes to make drugs. Alnylam is hoping to fix that yield problem. As Stuart Pollard, Alnylam’s vice president of scientific and business strategy explained in a chat today, the goal is to move beyond the crude modifications to temperature, pH, and nutrient content that companies make to improve biologics manufacturing yields. Alnylam’s idea was that siRNAs could be used to silence some of the proteins that contribute to cell death. Today’s data is an early look at how effective siRNA might be at improving yields. The company looked at two metabolic pathways that impact the viability of cells, and, though it was done at a small scale, did show that its siRNA was able to nearly double the number of cells that were active. “We see almost doubling of the viable integral cell tanks over that period of 15 days where we’re applying siRNAs,” Pollard said. Yes, you might say, but many others are looking at how to improve yield through new technologies. Merck didn’t pay $400 million for GlycoFi in 2006 for nothing: the biotech’s engineered yeast that can make consistent, complex proteins laid the groundwork for Merck’s biosimilars strategy. So why would using siRNA in manufacturing be an interesting proposition? Aside from improving yield, siRNA could be simply added to existing master cell lines. In other words, this is a process improvement that could be applied to drugs already on the market, those in development, and anything on the horizon. Still, these results were only at the one-liter scale, and Alnylam has yet to come out with data showing it has successful made a protein out of the process. Pollard says scale-up is underway, and more data will be forthcoming. But Pollard seems confident of its potential: “When will this application be used commercially? We think it could be pretty near term.” Any route that can make manufacturing of biotherapeutics more affordable...

Read More