Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
An Abbvie Inc. patent has disclosed thiazolo [5,4-b] pyridine compounds acting as mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitors reported to be useful for the treatment of activated B-cell like diffuse large B-cell lymphoma (ABC-DLBCL).
Current therapies based on immune checkpoint blockade are effective and offer a valid option for treatment, but many patients develop either primary or acquired resistance to treatment. Previous research has shown that the deletion of protein tyrosine phosphatases PTPN2 and PTPN1 results in an increase in the sensitization of tumor cells and the promotion of antitumor immunity.
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over.
A discovery-stage company founded 10 years ago and focused on developing a PINK1 activator for Parkinson’s disease and other indications is now under the umbrella of Abbvie Inc. through an acquisition potentially worth $655 million. North Chicago-based Abbvie paid $110 million at closing for San Francisco-based Mitokinin Inc., but the deal also includes up to $545 million in potential payments upon hitting development and commercial milestones related to the PINK1 (PTEN-induced kinase 1) program. On top of that, Mitokinin shareholders are entitled to tiered royalties based on net sales.
I-Mab Biopharma Co. Ltd. has regained full rights to its CD47 antibody program from Abbvie Inc., including lemzoparlimab, the most advanced candidate. The move, disclosed in a Sept. 22 U.S. SEC filing, eliminates the potential $1.295 billion in milestones associated with the amended collaboration deal signed in 2022.
I-Mab Biopharma Co. Ltd. has regained full rights to its CD47 antibody program from Abbvie Inc., including lemzoparlimab, the most advanced candidate. The move, disclosed in a Sept. 22 U.S. SEC filing, eliminates the potential $1.295 billion in milestones associated with the amended collaboration deal signed in 2022.
If the U.S. FDA has its way, biosimilars and interchangeable biosimilars would no longer be a difference with a distinction – at least when it comes to labeling. Instead of distinguishing between the two, the agency is recommending that the labeling for both follow-ons include a “biosimilarity statement.”
