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- Lupin has secured approval to manufacture and market its pegfilgrastim biosimilar in India, with production planned at its Nagpur facility in Maharashtra. - Pegfilgrastim is an onco-supportive therapy that helps the body produce neutrophils after chemotherapy to reduce the risk of serious infections and fever. - Lupin's Armlupeg is already approved in the US, where commercial rights are out-licensed to Valorum Biologics, while Biocon and Amneal also market US pegfilgrastim biosimilars.
- The FDA selected Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin for its new PreCheck pilot program aimed at accelerating domestic manufacturing facility reviews. - The program allows regulators to review new manufacturing facilities during construction, potentially saving companies up to 14 months in approval timelines. - Lilly's Lebanon, Indiana API facility for GLP-1 medicines and Regeneron's $2 billion Saratoga Springs, New York biologics site are among the selected projects. - The initiative is part of a broader Trump administration push to strengthen domestic drug manufacturing and improve U.S. supply chain resilience.
- The U.S. Food and Drug Administration has notified manufacturers to update prescribing information for Parkinson's drugs containing carbidopa or levodopa with new seizure risk warnings. - FDA safety review identified 14 cases of seizures linked to vitamin B6 deficiency in patients using these medications, which can become severe and prolonged. - Healthcare professionals are now advised to evaluate vitamin B6 levels before starting patients on these drugs and consider supplementation when necessary. - The seizure risk stems from these drugs depleting vitamin B6 levels during the conversion process of levodopa to dopamine in the brain.
- The FDA approved Accord's Osvyrti/Jubereq (denosumab-desu) on November 20, 2025, marking the eighth biosimilar approval for Amgen's blockbuster osteoporosis drugs Prolia and Xgeva. - Amgen reached a confidential settlement with Hikma and Gedeon Richter on November 24, 2025, preventing commercial launch of their denosumab biosimilars until January 1, 2026. - Multiple denosumab biosimilar applications remain pending at FDA, including products from Teva, Amneal, and Alvotech/Dr. Reddy's, with ongoing patent litigation cases. - Amgen reported combined U.S. sales of $4.392 billion for Prolia ($2.885 billion) and Xgeva ($1.507 billion) in fiscal year 2024.
- Metsera raised $215 million in a Series B funding round to advance its portfolio of GLP-1 receptor agonists for weight loss, bringing its total funding to over $500 million. - The lead asset, MET-097i, a long-acting injectable GLP-1RA, showed a 7.5% reduction in body weight over 36 days in Phase I trials, with Phase II data expected in H1 2025. - Metsera is also advancing MET-233i, an ultra-long-acting injectable, and MET-002, an oral GLP-1RA, with plans to explore combination therapies for enhanced efficacy. - The company has partnered with Amneal to establish manufacturing facilities in India, ensuring large-scale supply of its weight loss medicines.
- The FDA has approved Amneal's pyridostigmine bromide ER tablets (105 mg) for pretreatment against soman nerve agent poisoning in adults. - This once-daily oral medication, developed for the U.S. armed services, offers improved compliance compared to the current three-times-daily regimen. - The extended-release formulation utilizes Amneal’s Grande drug delivery technology for sustained 24-hour drug release. - Development was partially funded by the U.S. government, highlighting Amneal's commitment to innovative solutions and supporting the U.S. military.
- The Federal Trade Commission has challenged over 400 pharmaceutical patent listings in the FDA's Orange Book since September 2023, claiming many are improperly listed to delay generic competition. - Only three companies—GlaxoSmithKline, Glaxo Group, and Kaléo—have voluntarily delisted patents, while the vast majority of challenged listings remain in force. - The challenged patents relate to drugs generating billions in revenue, including GSK's Trelegy Ellipta ($1.756 billion) and other respiratory medications. - The FTC has not yet brought formal enforcement actions, raising questions about the agency's authority in patent listing disputes traditionally handled by FDA mechanisms.
