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BIOSIMILARS APPROVAL PROCESS
Cipla is aiming for 40-50 global product filings in three years, says MD Achin GuptaCipla is charting its next growth phase with a strong focus on innovation, complex generics, and biosimilars. The company plans significant...- Innovation, biosimilars, complex generics to drive Cipla's growth: Achin Gupta, MD & Group CEOAs Cipla approaches its centenary, the company is redefining its strategy by prioritizing innovation to amplify revenues. With ambitions to...
- 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 to acquire Organon for $11.75 billion in India’s biggest pharma dealSun Pharma, led by Dilip Shanghvi, has agreed to acquire US-based Organon in an all-cash deal worth $11.75 billion, marking the largest acq...
- 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...
- Zydus barred from selling cancer biosimilar, for nowThe Delhi High Court has temporarily barred Zydus Lifesciences from selling its breast cancer drug Sigrima, a biosimilar of Roche's Perjeta...
- Dr Reddy's Laboratories jumps into the fray for Biogen's biosimilarsDr Reddy's Laboratories (DRL) and Intas Pharmaceuticals, both Indian companies, are reportedly in the race to acquire the biosimilar produc...
- Will Biocon's foray into biosimilar boost its bottomline?Biological drugs are harvested from living organisms or certain components of living organisms. These drugs are very specific and highly ef...
- Stock pick of week: Biocon is on fast track to growth, making it analysts' top betStrong annual results for 2018-19 including improvement in net profit, growth momentum in its biosimilars business and recent price correct...
- Intas launches biosimilar Bevacizumab with aggressive pricingBiosimilar drugs are the follow on versions of biologic drugs which are composed of sugars, proteins, nucleic acids or complex combinations...
- 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...
- Delhi High Court gives Biocon, Mylan green light to market blockbuster biosimilar for three cancersThe court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and M...
- Court battle over Zydus Cadila's breast cancer drug continuesLegal experts said that the court is still in the process of hearing arguments from both sides to ascertain whether Roche could have approa...
- Delhi High Court defers order blocking Gennova’s stroke drugGennova's drug can't be approved as a biosimilar of tenecteplase as the original drug isn't prescribed for strokes, argued P Chidambaram, c...
- 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...
- Delhi High Court asks Roche to explain lawsuit over Avastin copyRoche, which invented the drug and markets it under the blockbuster brand ‘Avastin’, has argued that Hetero’s drug is not a biosimilar to b...
- 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.
- 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...
- Biocon, Mylan challenge ban on using Roche dataBangalore-based Biocon and US generic drugmaker Mylan have challenged Delhi High Court’s interim order which barred them from using Roche’s...
- Panacea, Intas plan biosimilar launchJoining Indian pharma majors who are targeting the $65-billion global biotech drug market.
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