By Donald Zuhn --
Biosimilar Approval Pathway: Who Will Be First?
Since President Obama signed the Patient Protection and Affordable Care Act into law in March, thereby establishing an approval pathway for biosimilar biological products, interested obsevers have been wondering whether the regulatory pathway would be utilized, and if so, who might be the first to step up to the plate. The questions are valid because the 17-page sliver of the almost 900-page health care reform package that concerns the biosimilars regulatory pathway raises a number of questions and issues that could lead some to take a wait and see approach.
In the past few months, however, there have been a handful of reports that provide hints of who might take the first crack at the new pathway. For example, Venture Capital Dispatch, a Wall Street Journal blog, noted last month that San Mateo, California-based Itero Biopharmaceuticals Inc. licensed its biosimilar version of recombinant follicle stimulating hormone, a treatment for female infertility, to Watson Pharmaceuticals Inc. ("A Race to Develop Better-Performing Biopharmaceuticals").
A Reuters report in July opined that the biosimilars market, projected to be worth $10 billion by 2015, would be "limited to a close circle of specialist companies with the means to invest heavily and to fend off a legal onslaught" ("Battle over Biosimilar Drugs Is Only for the Brave"). The article offers Merck & Co., which has created a biosimilars unit, and AstraZeneca, which the article reports has plans to enter the biosimilars field, as examples of future players. (Patent Docs readers may recall that Merck acquired a portfolio of biosimilar candidates from Insmed in February 2009; see "Follow-on Biologics News Briefs - No. 2".) The Reuters report also mentions Novartis' Sandoz unit, Teva, Hospira, and Stada as potential biosimilars players. The piece quotes a healthcare asset manager as saying that "only five to six players . . . are credibly going to play a role [in the biosimilars market]," suggesting that increased cost will play a big role in restricting the number of players (noting that biosimilar development, production, and marketing costs are about 50 times higher than for generic small molecule drugs).
Study Sees Significant Growth in Biologics Market
In-Pharma Technologist reports that a recent study, conducted by Global Industry Analysts, predicts that biologic sales will top $158 billion annually by 2015, with antibodies emerging as the market leader. The study notes that the growth in the biologics sector will be driven in part by a desire for "stronger" patents covering biological products. If recent biosimilars studies hold true, the biosimilars portion of the biologic market will constitute just over 5% in five years.
Biosimilars Market Forecast
A report issued earlier this month by PharmaLive predicts that the biosimilar market will reach $10 billion by 2017. The report cautions, however, that "legislation regarding regulatory pathways and patent infringement could impact investment in this area." Canon Data Products Group editor in chief Andrew Humphreys notes that the uncertainty is due to the fact that "[b]iosimilars is an immature market, and its regulatory pathway has yet to be clearly defined." He also notes that "[t]here is strong opportunity for R&D-based companies with existing biotech capabilities in-house to succeed in this sector, but not as much opportunity for standard generic manufacturers unless they are able to invest heavily now and wait for their return on investment" (Canon Data Products Group publishes PharmaLive).