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BIOSIMILARS REGULATIONS
Govt outlines next phase of pharma growthThe government highlighted its achievements, reforms, and policy initiatives, aiming to boost exports from $31 billion to $50 billion by 20...- More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...
- The alchemist of Bengaluru: Kiran Mazumdar-Shaw began from a garageKiran Mazumdar-Shaw has named her niece Claire Mazumdar as successor, setting up a gradual leadership transition at Biocon. A pioneer who b...
- Aurobindo Pharma arm CuraTeQ gets Health Canada nod for biosimilarAurobindo Pharma announced a significant development today. Its subsidiary, CuraTeQ Biologics, has received a compliance notice from Health...
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
- Sun Pharma deal: Perception changer for Indian pharma sector? 10 pharma stocks with upside potential of up to 38%The Indian pharma sector made its initial global forays almost a quarter century ago. Companies sought out markets abroad, learnt to deal w...
- Dr Reddy's gets nod to roll out generic oral semaglutide drug"The formulation was clinically evaluated in a head-to-head comparative study conducted in India, which established the non-inferiority to ...
- Civil society organisations urge govt to scrap animal testing in biosimilar developmentCivil society organizations are urging the health ministry to eliminate animal studies in biosimilar development to lower production costs ...
- Comments sought on biosimilars guidelinesIndia's drug regulator has released draft guidelines for biosimilar drugs, inviting public comments within 30 days. These revised regulatio...
- 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 gets US nod to launch Stelara biosimilarBiocon Biologics has secured USFDA approval to launch the biosimilar of Janssen's Stelara by February 2025, targeting autoimmune conditions...
- Dr Reddy's completes clinical studies of its proposed rituximab biosimilar candidateFollowing completion of the full set of clinical studies, Dr Reddy's said it will now prepare to file in the US, European Union and other r...
- Biocon reports 64% jump in Q4 net riding on biologicsBiocon reported a 64 per cent jump in its net profit for the quarter ending March 2019.
- Mylan-Biocon's breast cancer biosimilar gets ANVISA nodBiosimilar trastuzumab, indicated for breast cancer treatment, has been co-developed by Biocon and Mylan.
- Roche vs Indian Pharma: The battle for a cheaper cancer drugThe companies in the thick of it are Roche, a $51 billion Swiss pharma major, and Biocon, the Bengaluru-based company led by India’s first ...
- India offers better opportunity for biosimilar drugs: Cadila Healthcare founder Pankaj PatelBiosimilars are follow-on versions of biologic drugs and far more complex and more difficult to copy than generic drugs because of the stru...
- Make in India: Can India be a hub for the $200 billion worth biosimilars opportunityThe Indian biogenerics industry is poised to exploit the opportunity they did in the case of generics, although it has no clear advantage a...
- Biocon gets DCGI nod to market biosimilar trastuzumab in IndiaBiocon today said it has received approval from the Indian drug regulator to market its biosimilar trastuzumab developed jointly with Mylan.
- Biocon gets DCGI nod to market biosimilar trastuzumab in IndiaBiocon said it has received approval to market its biosimilar trastuzumab developed jointly with Mylan for treating breast cancer.
- Panacea, Intas plan biosimilar launchJoining Indian pharma majors who are targeting the $65-billion global biotech drug market.
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