The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug...more
On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all...more
FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab).
FDA also approves its third biosimilar version of Neupogen® (filgrastim). ...more
FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab).
FDA has approved only two biosimilars in 2021 after only approving three in 2020.
EMA approves four more Avastin® (bevacizumab) biosimilars,...more
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira®...more
On July 27, 2021, Amgen announced that it will acquire Bay area-based Teneobio, a privately held, clinical stage biotechnology company developing multispecific and bispecific molecules including biologics called Human...more
Elizabeth Holmes, former CEO of the now-defunct blood-testing technology company Theranos, recently learned a harsh lesson on the complexities and pitfalls of attorney-client privilege. As a result of a June 3, 2021 ruling...more
- FDA has not approved any biosimilars in 2021 after only approving three in 2020.
- EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira®...more
Cadent Therapeutics, a Cambridge, Massachusetts-based, privately held clinical stage biopharmaceutical company focused on the development of therapies for the treatment of cognitive, mood, and movement disorders, announced on...more
• FDA has only approved two biosimilars in 2020.
• No biosimilars have launched in the U.S. since April 2020.
• EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin®...more