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BIOSIMILARS GUIDELINES
Sun Pharma closes in on Organon buy, gets set for $12 billion binding bidSun Pharmaceutical Industries is nearing a $12 billion acquisition of Organon & Co, marking its most significant overseas expansion. Follow...- US biosimilar norms to keep local drug cos in good healthWith the new regulations set by the US FDA, the pathway to creating biosimilars will be both faster and more cost-effective. This developme...
- 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...
- Understanding the biosimilars opportunity for Indian pharmaBiosimilars to biologic drugs are what generics are to chemical drugs.
- 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 ...
- EMA accepts Biocon and Mylan's regulatory submission for proposed breast cancer biosimilar drugBiocon and Mylan are engaged in a court battle in India against Swiss biotech firm Roche over marketing restrictions imposed on their trast...
- Now, Roche takes Zydus Cadila to court over breast cancer drugThe petition states the approval of Cadila’s drug as a biosimilar has caused Roche “irreparable damage” in violation of applicable law for ...
- Government set to release revised biosimilar guidelines in July 2016The ministry expects the final guidelines to uphold the safety and efficacy of biosimilar drugs hitting the Indian market through stringent...
- Biocon, Mylan likely to appeal Delhi HC ruling on Roche's cancer drug trastuzumabThe order, which raised questions on the processes followed by the Indian drug controller in approving such drugs, could also affect the av...
- Changes proposed in norms to speed up approvals for biosimilarsBiosimilars are copies of complex drugs based on living cells. They are different from chemical-based generic drugs, which are 'identical' ...
- Health ministry plans to revamp regulatory rules for biosimilar drugsOfficials say the new norms will be finalised after consultations with the industry, academic institutions and stakeholders like the civil ...
- Biocon targets emerging, developed markets with biosimilars"Biocon aims to provide high quality biosimilars to patients across the world, both in emerging and developed markets," Kiran Mazumdar-Shaw...
- Intas Pharmaceuticals to launch its first biosimilar in US in 9-12 monthsIntas is the only domestic firm with two biosimilars filed for registration in the US and it looks to deliver affordable and innovative pha...
- Health groups lash out at HC order baning Biocon, Mylan from selling biosimilar breast cancer drugPublic health groups lashed out at High Court order that stopped Biocon, Mylan from selling biosimilar versions of breast cancer drug Herce...
- Roche sues Biocon, Mylan, DCGI over breast cancer drugRoche has sued Mylan, Biocon for launching biosimilar version of the original breast cancer drug, Herceptin, and DCGI for allowing the laun...
- Lobby fears norms violation in Cipla's biosimilar drugA lobby group of biotech drug companies in India has raised concerns about the approval of Cipla's first biosimilar drug Etanercept.
- Biosimilar products development gets a USFDA norms boostA biosimilar is a product that is similar to a biologic, which in turn is any drug produced through a biological route rather than chemical...
- Market for biosimilars is very large in emerging markets: Kiran Mazumdar ShawIn an interview with ET Now, Kiran Mazumdar Shaw, Chairperson & Managing Director, Biocon, talks about the biosimilars market.
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