Abbott filed a citizen petition with the U.S. Food and Drug Administration on 2 April 2012, asking the agency to refrain from accepting Biosimilars applications under the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA, which provides an approval pathway for Biosimilars biological products and constitutes a portion of the Patient Protection and Affordable Care Act that was signed into law on March 23, 2010, allows the FDA to accept Biosimilars applications four years after a reference product has been licensed and to approve such applications twelve years after the reference product has been licensed. Abbotts’ patent on Humira® is set to expire in December 2016.
Abbott
has highlighted following points that "the reference product sponsor has invested massive amounts of capital . . . and has taken great risk to develop, test, and seek a license to market the reference product," Abbott argues tha
t "an innovator's resulting license application typically reflects more than a decade of research and contains analytical, preclinical, and clinical data, as well as detailed manufacturing information, most of which qualifies as trade secrets," and contends that "these trade secrets are the private property of the reference product sponsor.
According to Abbott's Petition, "when FDA approves a Biosimilars biological product on the grounds that the reference product has been shown safe, pure, and potent, it uses these trade secrets."
Abbott also notes that when it submitted its BLA for Humira® in 2002, the company "had no notice, or reasonable expectation, that the agency would use its trade secrets to approve another company's product," and in fact, had "developed and submitted those trade secrets in reasonable reliance on FDA's lack of legal authority to approve Biosimilars, confirmed by years of agency statements that it lacked such authority." The Petition suggests that other innovators who submitted pre-enactment BLAs also "reasonably expected -- on the basis of applicable law and agency statements -- that the trade secrets contained in their applications would not be used to benefit a competitor."
Abbott also expresses a belief "that at least three companies have begun preclinical and/or clinical testing of Biosimilar adalimumab," but notes that it "does not know whether FDA is advising any companies about the contents of a Biosimilars application citing approval of Humira®.
The FDA continues to collect comments regarding Abbott's Citizen Petition, and has thus far received comments from the Generic Pharmaceutical Association (GPhA), Therapeutic Proteins International, LLC (a manufacturer and supplier of finished Biosimilars recombinant therapeutic proteins products), and Zuckerman Spaeder LLP (a litigation firm). Each of these commenters has asked the FDA to deny Abbott's Petition. Last month, the Washington Legal Foundation (WLF), a public interest law and policy centre, became the most recent group to submit comments on Abbott's Citizen Petition, but in contrast with the GPhA, TPI, and the Zuckerman firm, submitted its comments in support of Abbott's Petition.
The WLF's commented that any company that submitted a biologics license application (BLA) to FDA after adoption of the BPCIA in 2010 was on notice that FDA would be using information submitted in support of the application to evaluate the safety of Biosimilars. But many if not all companies that submitted a BLA to FDA before adoption of the BPCIA (including Abbott, which submitted an application for Humira® in 2002) would very reasonably have believed that their trade secret information would not be used to assist their competitors in this manner and, on the basis of that belief, invested heavily in the development of their biological product. As a result, the WLF supports Abbott's request that the FDA not approve any application or any investigational new drug (IND) application for a Biosimilars that cites a reference product for which the BLA was submitted to the FDA prior to March 23, 2010.
FDA has held 21 Pre-IND sponsor meetings, has received 35 Pre-IND meeting requests for proposed Biosimilars to 11 reference products, and has received 9 INDs. FDA has not yet even approved (let alone filed) a Section 351(k) biosimilar application submitted pursuant to the procedures established by the BPCIA.
On the comments received from GPhA, FDA has stated that the 2010 law expressly states that an interchangeable biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. Substitutability helped spur the growth of the generic drug industry at an earlier time and is similarly essential to help foster competition in the biologic drug market. Ultimately, such competition will spur innovation, improve consumer choice and drive down medical costs. The high standards for approval of biosimilar and interchangeable products mean that patients and health care professionals can be assured that, when these products go to market, they will meet the standards of safety, efficacy and high quality that everyone expects and counts on. Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower cost treatments. FDA does not have a position on any particular state legislation, but it is important for everyone to approach these issues with an understanding of both FDA's expertise in this area and what the 2010 law requires for approval of biosimilar and interchangeable products.
It is likely that the issues raised in Abbott’s Citizen Petition ultimately will have to be decided by the courts. The final outcome could impact the viability of the biosimilar framework, and have far-reaching effects on the biotechnology industry, as well as on healthcare costs and patient care.
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