Hogan Lovells Launches Biosimilars Law Blog
23 February 2012
WASHINGTON, D.C., 23 February 2012 – Hogan Lovells announced today the launch of the Biosimilars Law Blog, a one-stop resource for regulatory and legal information on medicines made from living cells, including biosimilar versions of innovator biotechnology products.
Led by the firm’s Pharmaceutical and Biotechnology Practice Group, the blog coincides with the U.S. Food and Drug Administration’s (FDA) recent release of a series of draft guidance documents on the Biologics Price Competition and Innovation Act of 2009, which was designed to create a regulatory pathway for the approval of biosimilars while also protecting the investment-backed interests of innovator biotechnology companies.
The release of the highly anticipated FDA guidance documents is a major development both for companies planning to develop biosimilars and for innovator companies who will face added competition. For the first time, FDA has outlined the critical steps in the process for developing a biosimilar, including the types of analysis and studies that will be needed to prove the safety and effectiveness of these products.
“The industry has been closely following the development of a biosimilars pathway for more than a decade. These new guidelines are the most comprehensive summation by the agency on the launch of the biosimilars program,” said David Fox, partner in Hogan Lovells’ FDA Pharmaceutical and Biotechnology Practice Group. “We look forward to helping our clients understand the new program – as well as comparable programs in Europe, Asia, and other regions – by providing an easy-to-use blog where they can find key documents and timely and relevant content.”
Because biosimilars are being developed worldwide, particularly in the EU and Asia, the blog will also offer an international perspective with contributions from Hogan Lovells’ global Life Sciences Practice.
“This blog will provide global resources and news on biosimilars, a critical area for our clients and one that our firm is proud to be on the forefront of in terms of regulatory updates and legal guidance,” said Asher Rubin, global co-head of Hogan Lovells’ Life Sciences Industry Sector Team.
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, including many with experience at the FDA and other key agencies and in the industry, and others holding advanced degrees in relevant disciplines, Hogan Lovells offers timely, effective counsel on a wide variety of matters that include product development, approval and post-approval compliance, and the development of next-generation products.
Hogan Lovells’ multidisciplinary team leverages the skills and experience of colleagues in other disciplines—including healthcare compliance (such as coverage, reimbursement, pricing, and fraud and abuse prevention), public policy, intellectual property, corporate and securities law, and litigation—to provide integrated, strategic, and practical advice for successful product development and marketing and effective responses to regulators and competitors. The firm’s global network of 2,300 lawyers in more than 40 offices supports client’s multinational and cross-border strategies, opening their innovations to a global presence that maximizes their potential.
Hogan Lovells lawyers David Fox, Phil Katz, and Lynn Mehler, and Regulatory Affairs Director Marie A. Vodicka, will serve as the blog’s U.S. editorial board.