By Anna Rose Welch, Editor, Biosimilar Development
Despite the fact biosimilars pose a big threat to the company’s novel biologics, Dr. Alpna Seth, Biogen’s VP and head of the biosimilars business unit, says jumping into the biosimilar space was a natural move for the company because of its advanced biologics capabilities.
By Joseph Reisman, Sheila Swaroop, and Scott Seeley, Knobbe Martens
Biologics exclusivity was one of the most controversial issues holding up the recently finalized Trans-Pacific Partnership (TPP) negotiations. Following the release of the official text of the TPP, there are three intellectual property provisions that biologics and biosimilar makers will need to keep in mind as they continue to navigate the global market.
By Winston Brown, VP of Global Quality, Phillips-Medisize
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.