Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
Boomerang Medical Inc. knocked out its first target with a U.S. FDA breakthrough device designation for its bioelectronic device for treatment of inflammatory bowel disease (IBD). The technology stimulates the parasympathetic nervous system to reduce inflammation for individuals with both types of IBD, Crohn’s disease and ulcerative colitis.
A slew of biosimilar versions of TNF-alpha inhibitor adalimumab will finally arrive on the U.S. market in 2023, almost seven years after the first such molecule, Amgen Inc.’s Amjevita (adalimumab-atto) gained U.S. FDA approval. Amgen commercially launched its product on Jan. 31. Seven more are lined up for launch over the summer, while two more are undergoing regulatory review. Their long-anticipated arrival will mark the beginning of the end for one of the most lucrative franchises in the history of the pharmaceutical industry. It represents, according to Cardinal Health Inc.’s newly published 2023 Biosimilars Report, “the largest loss of exclusivity event, perhaps ever in the U.S.”
Even though the EU had approved more than a dozen biosimilars by 2012, the follow-on biologics were still in their embryonic stage around the world when BioWorld published The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies in early 2013. Now, nearly a decade later, the global biosimilar landscape has matured with many more biosimilars approved across the globe, but the uptake, and thus the savings, is not what some policy makers and people in industry had hoped for or expected.
HONG KONG –Celltrion Group is partnering with Intract Pharma Ltd. to jointly develop an oral tablet form of infliximab. “Celltrion will supply the drug material through clinical evaluation and into the market, while Intract will be responsible for performing clinical studies,” Bill Lindsay, the CEO of Intract, told BioWorld.
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
HONG KONG –South Korea's leading biopharmaceutical developer, Celltrion Inc., has launched its early/metastatic breast and gastric cancer biosimilar Herzuma (trastuzumab) in Iraq. It is Herzuma's first foray into the Middle Eastern region.
