October 21, 2010
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Two 9-figure announcements this week mark a turning point for the biosimilars market, and one highlights the increasingly important role India plays in innovation.
- Pfizer linked up with India’s Biocon in a deal that will see Biocon take the lead in development of four biosimilar insulin products that gives Biocon $200 million up front. Coverage of the deal in the Business Standard highlights the country’s overall strength in biosimilars, which fall midway between new molecule development and small molecule generics in terms of the R&D and manufacturing sophistication required. Biocon cites the deal as proof that India can move up the value chain, doing for biosimilars what it did for generics. This is especially true if they continue to attract backing and partnerships from the Pfizers of the world.
- Novartis’ generics unit, Sandoz, reported Q3 revenues of $292 million from a single biosimilar product — enoxaparin, a copy of Sanofi-Aventis’ anticoagulant Lovenox — which is not expected to hit blockbuster status in its own right. As we have noted before, the high level of expertise required to make biosimilars creates a high barrier to entry and contributes to the field’s attractiveness to traditional pharmas (e.g., Pfizer, above) as well as to the major generics players. FierceBiotech notes further growth is expected as the first biosimilar antibodies hit the market in 2014-2015.
The Economist picked up the relevant trends in an article today entitled “Attack of the Biosimilars“:
1) “Innovator” pharmas are moving into the biosimilars business, reversing their recent role as the predominant plaintiffs in IP litigation:
“…it is ironic that the next great opportunity for traditional drugs firms is to do to the biotechnology interlopers exactly what the generics firms have done to them: shred their profit margins with cheaper copies…”
2) India in moving up the innovation value chain, increasing that country’s incentive to protect IP more forcefully:
“And as if to remind the world that new ideas don’t all come from America, it is the Indian firm that will design and manufacture the original drugs; Pfizer will only market them.”
Bottom line: biosimilars are at least as big a business as predicted. This success is another challenge to the concept that pharma’s patent cliff challenge will be met by more in-licensing from small biotechs or by increased R&D spending. Revenue is revenue, and biosimilars are poised to generate lots more of it.
April 22, 2009
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Guest post from Jill Daley, part of our all-star life sciences team at Ogilvy:
Today, Sandoz Canada announced that Health Canada has granted it a market authorization for Omnitrope™.
This announcement marks the approval of the first subsequent entry biologic (SEB, also known as a “follow-on biologic” (FOB) in the U.S. or a “biosimilar” in the EU) of a previously approved recombinant biotechnology drug by Health Canada.
Omnitrope™ has received similar treatment in the United States and in Europe where it has been approved as a “follow-on protein” and a “biosimilar” respectively.
Interestingly, today’s announcement came less than one month following Health Canada’s issuance of the Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics. The Ogilvy Renault bulletin analyzing the draft guidance is here.
The draft guidance is open to consultation until May 26, 2009. Interested stakeholders are invited to submit written coments via email (BGTD_PPD_DPP@HC-SC.GC.CA), mail or fax (613-952-5364).