FLH Partner Malkin Quoted in FDA News Article on Biosimilars - Upcoming Conferences Featuring Biosimilars
FDA Lawyers Blog is pleased to announce that FLH Partner Brian J. Malkin was quoted in an FDAnews article by David Pittman on June 20 commenting on biosimilars and the increasing innovator biological - generic drug pair-ups that have been occurring. Pittman's article focused on the latest Dr. Reddy's - Merck KGaA ("Merck") partnership that reportedly will focus on oncological, monoclonal antibodies. The plan calls for Dr. Reddy's to conduct early-phase research and development with Merck handling the later-phase clinical trials and scale-up manufacturing. In addition, Merck will commercialize the products in most parts of the world, paying Dr. Reddy's royalties, but in the United States, the companies will commercialize the products together on a profit-sharing arrangement.
Malkin was quoted as saying that the generic-biosimilar partnerships are becoming increasingly popular because they help split, the cost, risk, and difficulty in developing biosimilar products. He also explained that the partnerships make sense, because innovator companies are good and developing new products and marketing them, while generic companies are good at deformulating innovative products and finding ways to manufacture them at a lower cost. The partnerships further help to mitigate the inherent weaknesses with each party: innovators are not accustomed to many of the analytical techniques that FDA has said that it will require to demonstrate similarity between innovator biologics and the biosimilar counterparts, and generic companies are not accustomed to marketing their products (for the most part) or formulating biological products, which are much more resource intensive.
Malkin's observations were echoed by statements made by Merck in other arenas, with Merck executive board member Stefan Oschmann saying, "Sharing know-how, risks and rewards is the right approach to enter the emergent biosimilars market and will be a win-win for both parties." According to Merck, it had already factored the investments needed for this collaboration into its profit outlook.
Malkin will be speaking at two upcoming conferences featuring biosimilars next month, first in the Washington, D.C. Area on July 12 with Q1 Productions' Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars Conference and then in Boston on July 17 with the American Conference Institute's Clinical Trials Conference. Malkin's presentations will take advantage of his extensive knowledge of this developing field, fueled by his observation in recent meetings such as the Biotechnology Industry Organization's International Convention, where Malkin attended events featuring key FDA decision makers Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research, and Karen Midthun, M.D., Director for the Center for Biologics Evaluation and Research identifying key issues in their respective center and speaking about the future of biosimilars, as reported here. These events will be some of the first events to follow the eagerly-anticipated Supreme Court decision regarding the constitutionality of the Affordable Care Act, which possibly threatened the immediate future of biosimilars, if the Act is entirely overturned, as some has speculated.