Development

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

California's Governor Signs Bill for State to Produce Its Own Biosimilars, Insulins

September 29th 2020

By Skylar Jeremias

Article

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.

Byvasda Shines in Combination With PD-1 Inhibitor

September 28th 2020

By Skylar Jeremias

Article

Trial results demonstrated that Innovent Biologics’ bevacizumab biosimilar was effective in combination therapy with a PD-1 inhibitor in patients with hepatocellular carcinoma.

Alvotech and DKSH Broaden Their Asia Pipeline Agreement

September 28th 2020

By Skylar Jeremias

Article

A secretive biosimilars company notches yet another co-licensing deal but withholds full details.

Alexion's Ultomiris Gains aHUS Indication in Japan

September 26th 2020

By Tony Hagen

Article

An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.

Study: Switching From Reference Infliximab to CT-P13 Is Safe, Efficacious in IBD

September 24th 2020

By Skylar Jeremias

Article

The NOR-SWITCH study showed comparable safety, efficacy, and immunogenicity for patients with inflammatory bowel disease (IBD) who switched from reference infliximab to Celltrion biosimilar (CT-P13).

IGBA Seeks Waiver of Comparative Clinical Efficacy Studies

September 24th 2020

By Tony Hagen

Article

The International Generic and Biosimilar Medicines Association (IGBA) seeks to limit the use of comparative clinical efficacy studies to support biosimilar equivalency applications.