Search Results for:

Brian Burgess to speak at FDLI Annual Conference

The annual Food & Drug Law (FDLI) conference will be held on June 14-15, bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia to address complex legal, regulatory, compliance, and policy issues facing the FDA-regulated industry.  Goodwin is a…

Read More

Merck Completes Organon Spinoff

As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company.   This month, Merck completed the spinoff, creating Organon.  Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets.  Organon…

Read More

Global Biosimilar Update

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe.  As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube…

Read More

Now Available! Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 Edition

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products.  The BPCIA also introduced a new scheme to resolve…

Read More