BIO and Biosimilar Regulations throughout the World
[author: Andrew Williams]
The 2012 BIO International Convention in Boston begins next week. If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the Convention. Last week, we highlighted three sessions on how the Supreme Court's Prometheus case is impacting the BIO community. Today, we present opportunities for those interested in learning more about how the biotech industry is adjusting to the new biosimilar framework in various jurisdictions. Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#1335 – Hall A) to discuss the FDA's draft guidance documents on the new biosimilar approval pathway (or whatever other topic is of interest to you).
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act ("the Act"), which amended the Public Health Service Act to create an abbreviated approval pathway for biological products that are either biosimilar to or interchangeable with an already approved biological product. While the fate of the Act has yet to be determined by the Supreme Court, the U.S. is almost certain to begin seeing biosimilar drugs approved in the near future. In fact, in February of this year, the FDA issued three guidance documents that provided its thinking on key scientific and regulatory factors that will be involved in submitting applications for biosimilar products to the agency (see "FDA Publishes Draft Guidelines for Biosimilar Product Development"). However, the U.S. is not the first jurisdiction to consider a biosimilar pathway, and in fact Europe has already approved several biosimilar drugs via an abbreviated registration process. Of course, the subject of biosimilars is of great interest to the biotech community, and this year provides several opportunities for BIO attendees to attend sessions on the development of biosimilars regulatory schemes both here and outside the U.S.
Europe has led the way in creating a biosimilar approval pathway, and was the first to approve biosimilar drugs. Some of the key factors driving this process were patent expirations, cost containment measures, ageing populations, and supporting legislations. On Monday, June 18, between 10:00-11:30 am, the Health Policy and Reimbursement Track will present "Access to and Uptake of Biosimilars: The European Experience." This session promises to focus on market opportunities for both innovator companies and the generic industry in Europe. It will evaluate the challenges for the policy makers and payers in terms of pricing and reimbursement of biosimilars, as well as the challenges of providing patients, healthcare professionals and payers with adequate information. The panel for the session consists of Thomas Bols, Vice President Health Policy & Market Access, EuropaBIO; Paul Greenland, Biosimilars and Proprietary Marketing Director, EGA; and Steffen Thirstrup, Chief Medical Officer of the Danish Medicines Agency (DKMA). The session will be moderated by Thomas Heynisch, Deputy Head of Unit Healthcare, Biotechnology, of the European Commission, DG Enterprise and Industry.
Of course, Europe isn't the only area outside of the U.S. that has been establishing a biosimilar regulatory framework. Countries in Latin America have been actively making plans to become global leaders in biotechnology. Argentina published a dedicated biosimilar regulation in late 2010 and 2011, and Brazil developed new biologics regulations in the same timeframe, with product-specific guidelines for biosimilars. In addition, Mexico recently updated the Regulation of Health Supplies (RIS) in terms of biological medicine. To discuss these advances, the Global Innovations and Markets Track will present "Biologics and Biosimilars in Latin America: Are New Regulations and Guidelines in Brazil, Mexico, and Argentina a New Model for Drug Regulation?" on Wednesday, June 20 from 8:30-9:45 am. The panel promises to discuss the regulatory framework in Brazil and Mexico, because, in 2012, Brazil is finalizing its guidelines for biosimilar monoclonal antibodies, and Mexico is implementing it new biologics regulation. It is an objective of this session to distinguish the framework in these two countries from other emerging markets, and how the respective governments were able to achieve this change in regulatory framework. It is also an objective to learn from company executives working within these regulatory frameworks what matters most when deciding to enter and/or invest in a country. Currently, the session presenters are Dirceu Barbano, Director Chairman of ANVISA, National Health Surveillance Agency, and Laura Hamill, Vice President, Latin America for Amgen.
As a final example of a learning opportunity about biosimilars, the Achieving Regulatory Approval and Compliance Track is presenting "Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement" on Thursday, June 21 from 8:30-9:45 am. The U.S. may not be the first jurisdiction to create a biosimilar regularity pathway, or approve biosimilar drugs, but they are the only one to require an evaluation of interchangeability. In fact, Canada has explicitly rejected the notion of interchangeability. This session promises to summarize the state of the science of biotechnology, specifically with regard to a determination of interchangeability as defined by the U.S. law. Also, the panelists will discuss the challenges of implementing such a system, and how it will affect manufacturers, health care providers, patients and payers. Finally, they will look at the key public policy considerations involved. The panel will include Joseph Miletich, Senior Vice President, Research and Development for Amgen; Gregory Schimizzi, Co-founder of Carolina Arthritis, Coalition of State Rheumatology Organizations; Jan Wyatt, Patient Advocate for the Arthritis Foundation; and Richard Kingham, Partner at Covington & Burling LLP. The session will be moderated by Ramsey Baghdadi, Senior Editor of The RPM Report.
