Tag Archives: biosimilar

Drug Regulation

Delhi High Court Grants Biocon-Mylan Permission to Market New Biosimilar For Additional Indiciations


As reported in the Economic Times on March 4, 2017 a Division Bench of the Delhi High Court has passed an interim order allowing Biocon and Mylan to market their biosimilar of Roche’s drug, Herceptin, for two additional indications: early breast cancer and metastatic gastric cancer. (Although this order was passed on March 3, 2017 it took the High Court’s registry almost 13 days days to make available the order on its website. It is not clear why it took…


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Drug Regulation

Roche & Biocon sue each other for contempt in Herceptin biosimilar case while Roche and Hetero squabble over judge in Avastin biosimilar case


The ongoing biosimilar litigation between Roche and Indian generic companies is becoming more contentious with every passing day. ET’s Prabha Raghavan reported on July 15 that both Roche and Biocon are now suing each other for contempt before the Delhi High Court. As Rahul had reported earlier over here, Justice Manmohan Singh had passed orders in an earlier litigation restraining Biocon and its partner Mylan from using the name Herceptin (or associated Indian trademarks) while marketing its drug although he…


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Drug Regulation Innovation Patent

Roche Moves Delhi HC to Challenge the Approval Granted by DCGI to Yet Another Biosimilar


A couple of weeks ago, I had analyzed the Delhi High Court’s judgment here and here, delivered by Justice Manmohan Singh, imposing some conditions on the sale of Roche’s breast cancer drug, Trastuzumab (Herceptin), by Biocon and Mylan. While Justice Singh allowed Biocon and Mylan to sell the biosimilar of Trastuzumab subject to some conditions, the decision was appealed to a Division Bench which has allowed the two companies to continue marketing the drug till 21st July. On the heels…


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Data Exclusivity Drug Regulation Patent

Delhi HC Imposes Strict Conditions on the Sale of Biomedicines: Part 2/2


In part 1 of my analysis, I offered a brief summary of the Delhi High Court’s judgment imposing strict conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. Before I delve into the findings of the single judge, I should point out that, as one of the commenters to my previous article noted, the decision has been stayed by a Division Bench and the matter is listed to be next heard…


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