FDA OKs Immgolis as first golimumab biosimilar for UC, RA
The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a bio...
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The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a bio...
Samsung Bioepis announced Wednesday the launch of its Ustekinumab biosimilar in Japan, marking the company’s first product debut in the country under a partnership with NIPRO Corp....
The U.S. Senate Committee on Health, Education, Labor and Pensions on Wednesday cleared two bills for full Senate review, tackling the gap between health and patent oversight agenc...
The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experie...
By: Sabrina Serani From; targetedonc.com The FDA has approved an abbreviated new drug application (ANDA) for generic eribulin mesylate injection, offering a new therapeutic option...
This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry ad...
An analysis of the 67 ex parte reexaminations used to challenge biologics patents over the last 13 years reveals that reexamination may emerge as an alternative to inter partes rev...
For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.
Over the next year, countries that are home to 40% of the world’s population are set to get access to Ozempic and Wegovy generics that could cost as little as $15 a month.
Licencing agreement grants Ipca access to Bhami Research’s proprietary high-concentration subcutaneous biologics delivery platform for the development and commercialisation of mult...
Americans Can Access Affordable Generic Ozempic (Semaglutide) Through Reliable Canadian Prescription Referral Services
ASCO: Will New Drugs Demonstrate Benefits Over Generics? Anonymous (not verified) Sun, 05/31/2026 - 14:42 pharmagather item url ASCO: Will New Drugs Demons...
Health Canada approved both Dr. Reddy's and Apotex's generic semaglutide — the active ingredient in brand-name Ozempic and Wegovy — about three weeks ago.
The Supreme Court ruled that a knockoff version of Amarin’s Vascepa didn’t infringe on patents — a decision with far-reaching implications for the availability of generics.
Pharmaceutical groups and the Washington Legal Foundation backed Amgen in amicus briefs Monday urging the Fourth Circuit not to revive Sandoz's antitrust claims, arguing that if Sa...
The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Bruk...
Oral semaglutide, a glucagon-Like Peptide-1 receptor agonist (GLP-1 RA), is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes...
Retired U.S. Circuit Judge Paul R. Michel is backing Amgen against Sandoz's Fourth Circuit appeal, arguing in an amicus brief that the final say over now-nixed allegations of block...
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