Last month, the World Generic Medicines Congress Americas held its annual conference in Washington, DC. The conference was designed as an interactive session to examine the challenges facing the global biosimilars market and identify strategies to enter this potentially lucrative market.
The session focused on the regulatory environment, the growth strategies, and the challenges of launching and making a commercially viable biosimilar across numerous regions including Europe. It also addressed the additional regulatory uncertainty in the US and considerations for commercializing these new and complicated products.
There were a number of notable speakers at the conference from generic manufacturing companies, and government officials, including Congressman Henry Waxman (D-CA). In his speech, which focused on a congressional update regarding Hatch-Waxman Reform.
Congressman Waxman discussed in his speech the Biologics Price Competition and Innovation (BPCI) Act, which was included in the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010. BCPI amends the Public Health Service Act and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. In other words, the FDA now has the authority to approve biosimilars.
The BPCI Act includes a 12-year period of marketing exclusivity from the date of first licensure of the reference product.
According to FDANews, Congressman Waxman vowed to amend the 12-year period of exclusivity granted to manufacturers of brand biologics in healthcare overhaul legislation earlier this year. The Congressman said that the legislation as written would not help lower the cost of biologics and he would fight to have it changed. “The legislation did not balance appropriately the incentives for innovation with the incentives for competition,” Waxman said. “This was clearly an opportunity lost.”
Given that Waxman will soon lose his post as Chairman of the House Committee on Energy and Commerce, which has jurisdiction over health care through its subcommittee on health, it is unlikely that Mr. Waxman will see any significant movement or changes on this issue in the near future.