US FDA accepts Biocon's cancer drug application for reviewBiocon and Mylan’s proposed biosimilar bevacizumab, a cancer drug, is expected to be the third biosimilar from the partnered portfolio for ...
09 Mar, 2020, 10.13 AM IST
Biocon puts arthritis drug on backburnerBiocon and Mylan have been working for a decade on a biosimilar version of the drug, originally sold by Amgen under brand name Enbrel.
11 Jul, 2018, 12.09 PM IST
Biocon-Mylan's cancer drug gets USFDA nodFulphila is expected to contribute to Biocon’s revenue in FY19, as well as to its profits through a profitshare arrangement with Mylan.
06 Jun, 2018, 11.15 AM IST
USFDA okays Mylan, Biocon's biosimilar of cancer drug HerceptinOgivri is the first USFDA approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the...
02 Dec, 2017, 01.40 PM IST
Breast cancer biosimilar approval delayed as US FDA reviews additional information by Biocon, MylanBiocon and Mylan have together developed the trastuzumab biosimilar, which is a copy of a complex biologic drug developed by Swiss biotech ...
30 Aug, 2017, 08.40 PM IST
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...
04 Mar, 2017, 11.42 AM IST
HC allows Biocon, Mylan to sell their drug for three cancersBiocon and Mylan had appealed against the single judge order as restrictions were imposed on the use of clinical data in the package insert...
03 Mar, 2017, 06.03 PM IST
USFDA accepts Mylan's BLA for proposed biosimilar PegfilgrastimThe proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the ...
17 Feb, 2017, 04.12 PM IST
USFDA accepts Mylan's application for proposed biosimilar TrastuzumabThis is Mylan and Biocon's "first US regulatory submission through the 351(k) pathway and reinforces the strength of collaboration."
11 Jan, 2017, 09.43 PM IST
European Medicines Agency accepts marketing application of Biocon, Mylan productMylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients.
03 Nov, 2016, 08.48 PM IST
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...
25 Aug, 2016, 09.00 PM IST
EMA accepts marketing application of Biocon, Mylan productMylan and Biocon, who co-developed the proposed biosimilar, received EMA's acceptance of the submission for review, Biocon said in a statem...
21 Jul, 2016, 09.36 PM IST
Reliance Life Sciences appeals marketing restrictions on breast cancer drugThe counsel is appealing conditions including the restrictions placed on the labelling of TrastuRel as well as those placed on using Roche’...
04 Jun, 2016, 04.28 AM IST
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...
17 Feb, 2014, 05.16 AM IST
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.
27 Nov, 2013, 02.30 AM IST
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.
26 Nov, 2013, 05.11 PM IST
Biocon Inks Pact with Mylan for generic insulinIn 2009, Mylan and Biocon had come together to develop five blockbuster biologic drugs in cancer and pain areas.
15 Feb, 2013, 05.00 AM IST