Indian multinational pharmaceutical company based in Hyderabad, manufacturing and marketing pharmaceuticals internationally; produces over 190 medications, 60 active pharmaceutical ingredients, and diagnostic kits.
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1984
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- The Unified Patent Court revoked Sanofi's patent EP 2 493 466 protecting the anti-tumor use of cabazitaxel in combination with prednisone or prednisolone for treating hormone-refractory metastatic prostate cancer. - Multiple generic companies including Accord Healthcare, Zentiva, Stada, and Dr. Reddy's successfully challenged the patent through counterclaims for revocation at the Munich local division. - The court's decision follows similar rulings in France and earlier favorable decisions for generics in the UK and Germany, allowing generic versions of the chemotherapy drug Jevtana to enter European markets.
- 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.
- The European Commission has approved Alvotech's AVT03 as a biosimilar to denosumab, providing access to an estimated $1.2 billion European market for osteoporosis and cancer-related bone complications. - The approval was based on extensive analytical and clinical data demonstrating equivalent pharmacokinetics, efficacy, safety, and immunogenicity to the original denosumab products Prolia and Xgeva. - Dr. Reddy's will lead commercialization in Europe under the Acvybra and Xbonzy brand names, marking a significant regulatory milestone for Alvotech's biosimilar platform. - Despite this European success, Alvotech faces ongoing challenges with FDA concerns regarding its AVT05 product and manufacturing facility inspections in the United States.
- Alvotech announced significant leadership changes with Chief Commercial Officer Anil Okay stepping down to become CEO of Adalvo, marking a strategic transition in the company's commercial operations. - The biosimilar company appointed three experienced pharmaceutical executives to key positions: Trisha Durant as Senior VP of Global Business Development, Harshika Sarbajna as Senior VP Commercial North America, and Agne Pasko as VP Head of Business Development. - The leadership restructuring comes as Alvotech continues expanding its global commercial partnerships for biosimilar medicines, with two products already approved and nine candidates in development targeting autoimmune disorders, cancer, and other therapeutic areas.
- Rigel Pharmaceuticals' lead product Tavalisse generated $68.5 million in sales during the first half of 2025, representing a 44% year-over-year increase. - The company's second FDA-approved drug Rezlidhia showed strong momentum with 31% year-over-year growth to $13.1 million in sales. - Rigel raised its 2025 revenue guidance to $270-$280 million from the previous expectation of $200-$210 million due to strong commercial performance. - The company is advancing R289, a dual IRAK1/IRAK4 inhibitor, in Phase Ib trials for myelodysplastic syndrome with dose expansion planned for the second half of 2025.
- President Trump announced 100% tariffs on all imported branded and patent-protected medicines to the US starting October 1, 2025, unless companies are actively building manufacturing plants in America. - Indian pharmaceutical stocks plummeted up to 5% following the announcement, with Sun Pharma hitting its yearly low and the Nifty Pharma Index declining 2.54%. - The policy could significantly impact Indian pharma companies that generate substantial revenue from US exports, potentially affecting over $233 billion of US pharma imports while exempting generic drug exporters. - Companies may face reduced profits or be forced to invest in expensive US manufacturing facilities to avoid the tariffs and maintain market access.
- Alvotech, a global biosimilar medicines company, has appointed Linda Jónsdóttir as Chief Financial Officer, bringing 15 years of senior leadership experience from Marel food processing technology company. - Joel Morales, who served as CFO since 2020 and helped transform Alvotech from a private R&D-focused company to a profitable public biosimilars leader, is stepping down to prioritize family time. - Jónsdóttir's appointment comes as Alvotech continues its rapid growth trajectory with two approved biosimilars already marketed globally and nine additional candidates in development pipeline.
- Coya Therapeutics is advancing its regulatory T cell-derived exosome (Treg exosome) platform with plans to initiate GMP manufacturing of clinical batches by Q4 2025, positioning it for first-in-human trials. - Preclinical research demonstrates Treg exosomes effectively suppress pro-inflammatory responses, with intranasal administration in mouse models showing promising results in slowing disease progression and increasing survival. - The Treg exosome platform complements Coya's existing pipeline, including COYA-302, targeting the $59 billion neurodegenerative disease market that is expected to reach $83 billion by 2030.
- Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility. - Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet. - The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.
- Dr. Reddy's Laboratories has launched Toripalimab in India, an immuno-oncology drug approved for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). - India is now the third country, after the U.S. and China, to have access to this next-generation PD-1 inhibitor, marketed as Zytorvi. - Clinical trials showed that Toripalimab, combined with chemotherapy, reduces the risk of disease progression or death by 48% in RM-NPC patients. - Toripalimab is also approved as a monotherapy for adults with NPC who have disease progression following platinum-containing chemotherapy.
