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BIOSIMILAR APPROVALS
Dr Reddy’s Q2 Results: Net profit falls 36% YoY to Rs 913 crore, revenue declines marginallyDr Reddy’s Laboratories reported a 36% year-on-year profit decline to Rs 913.4 crore in Q2 FY27, while revenue slipped 1.5%. North America ...- Dr Reddy's gets DCGI nod for Zytorvi in advanced esophageal cancerDr Reddy's Laboratories has received approval for Zytorvi, an immunotherapy targeting advanced esophageal squamous cell carcinoma. This new...
- Biocon clears path for cancer drug launchBiocon has finalized a global settlement and license agreement with Genentech for its drug Pebrilzo. This agreement addresses all ongoing l...
- Zydus moves closer to US market for Keytruda biosimilar as FDA accepts applicationZydus Lifesciences has received acceptance for its application regarding the biosimilar of Keytruda, which is a major cancer drug. The USFD...
- CPHI Milan: Beyond generics, how Indian pharma is rewriting its global playbookAt CPHI Milan, Indian pharma players are looking beyond traditional exports, using partnerships, licensing, CDMO, and differentiated produc...
- MF Tracker: HDFC Pharma & Healthcare Fund tops equity MFs at 25% in 1 year. Should investors chase the rally?HDFC Pharma and Healthcare Fund recorded an impressive 25% return in the last year, surpassing its category average across various time fra...
- Biocon arm gets positive EMA panel recommendation for breast cancerbiosimilar PebrilzoBiocon Biologics has received a positive recommendation from the European Medicines Agency’s CHMP for its Pertuzumab biosimilar, Pebrilzo, ...
- Dr. Reddy's launches nivolumab biosimilar in IndiaDr Reddy's Laboratories has taken a significant step in cancer care with the introduction of NIVORZ, a biosimilar of nivolumab. Designed to...
- Sandoz bets big on biosimilars, aims to double group sales by 2035Sandoz plans to more than double annual net sales by 2035, with biosimilars leading growth. The company will expand its biosimilar portfoli...
- Sun Pharma gets ratings boost from Moody's, S&P over USD 11.75-bn Organon & Co acquisition bidRating agencies Moody's and S&P assigned investment-grade ratings to Sun Pharmaceutical Industries. This action follows Sun Pharma's propos...
- Lupin gets USFDA approval for Modafinil tablets to treat excessive sleepinessPharmaceutical major Lupin announced its USFDA approval for Modafinil tablets. These tablets are used to treat excessive sleepiness in adul...
- Cipla, China's Qilu partner for US launch of Merck's Keytruda biosimilarCipla said its US unit has entered an exclusive partnership with China’s Qilu Pharmaceutical to license QL2107, a biosimilar of Merck’s can...
- Biocon arm gets Japan nod for cancer drug pegfilgrastim biosimilarIn a significant advancement, Biocon Biologics has gained marketing approval for its pegfilgrastim biosimilar in Japan. This vital cancer s...
- Biocon shares rise 2% after USFDA approval for Yesintek single-dose prefilled autoinjectorBiocon shares rose after its US subsidiary received supplemental FDA approval for Yesintek single-dose prefilled autoinjectors in two stren...
- Aurobindo Pharma shares in focus after European Commission nod for cancer drug DazublysAurobindo Pharma's subsidiary, CuraTeQ Biologics, secured European Commission approval for its trastuzumab biosimilar, Dazublys, indicated ...
- Revised rules for biosimilar drugs enter the final stretchThe Indian government is refining biosimilar drug regulations, aligning with global standards to ensure stringent quality in research and m...
- Biocon Biologics, Viatris receive approval for cancer drugAbevmy is approved for treatment in metastatic colorectal carcinoma, metastatic breast cancer, non small-cell lung carcinoma, glioblastoma,...
- Biocon teams up with Swiss drugmaker Sandoz for next gen biosimilarUnder the terms of the agreement, both companies will share responsibility for end to end development, manufacturing and global regulatory ...
- USFDA is trying to approve biosimilars and evolve the process concurrently: Kiran Mazumdar Shaw, Biocon"Our clinical data package has been approved by ODAC recently, and the GMP part of the regulatory process has already seen us-- provide a s...
- Roche’s reputation at stake if Avastin biosimilar approved without trial: Kapil SibalThe judge asked the company to submit a compilation of judgments highlighting the protection given to drug innovators to support its call.
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