Charles River Biopharmaceutical Services (BPS) wants to keep you up-to-date on the changing regulatory environment of our industry. This page will include summaries and links to relevant regulatory documents that are either under discussion or recently published.
Biosimilars/Follow-On Biologics/Subsequent Entry Biologics*
With the adoption of recent healthcare reform legislation in the US, the development of biosimilars is making headlines. On March 23, 2010, President Barack Obama created a legal pathway for biosimilars in the US by signing the Patient Protection and Affordable Health Care Act (PPACA), which contains the Biologics Price Competition and Innovation Act (BPCIA), into law. The FDA has been tasked with defining the scientific and regulatory path for the approval of biosimilars.
Although the FDA has not yet issued any guidance on the approval for biosimilars, the first steps toward implementation of the law were taken in the form of a public hearing on November 2-3, 2010, where an FDA panel comprised of senior agency leadership sought input from a range of experts on the critical issues and challenges relating to implementation of the BPCIA. The FDA sought input from interested stakeholders on nine different topics posed in the Federal Register announcement of the public hearing. Questions asked by the agency were grouped into the following areas:
A total of 43 individuals testified at the public hearing, including a US senator, physicians, patients and representatives from patient advocacy groups and industry (innovator and biosimilar). Each presenter was allotted eight minutes for a presentation, with an additional seven minutes being allotted following each presentation for the FDA panel to ask questions.
The FDA described the hearing as a critical milestone in its implementation efforts. The agency will take the information obtained from the meeting into account in its implementation of the BPCIA and in the development of related guidance documents and rule-making. The public is invited to comment on the agency’s questions via the docket until Dec 31, 2010. More information on the meeting can be found at http://www.fda.gov/Drugs/NewsEvents/ucm221688.htm.
Recent developments in biosimilar legislation are not just limited to the US. The European Medicines Agency (EMA) has released a draft “Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies.” This draft guideline contains the EMA’s expectations for clinical and nonclinical study requirements for developing biosimilar monoclonal antibodies. With several blockbuster monoclonals due to come off patent in the next few years, this document is crucial to any company interested in entering the biosimilar market for these products. The EMA guideline is the latest in a series of molecule-specific guidance available within the EU framework for biosimilar approvals, joining EPO, GC-SF, insulin and interferon-α.
*Content adapted and excerpted from “Implementation of Approval of Biosimilar Products in the United States” by Andrea Weir and Barbara Mounho, published online in Volume 1, Issue 3, of the Society of Toxicology Biotechnology Specialty Section newsletter. Used with permission of the authors and the Society of Toxicology.