Biocon, Mylan launch insulin biosimilar in AustraliaThe biotechnology major and pharmaceutical company Mylan N V announced the launch of their insulin biosimilar Semglee.
03 Oct, 2019, 03.18 PM 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
Mylan-Biocon’s insulin biosimilar faces FDA hurdleFirms have been asked to share details about a change in the manufacturing site for glargine from Bengaluru to a new facility in Malaysia.
02 Jun, 2018, 10.37 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
USFDA issues CRL for proposed biosimilar Pegfilgrastim: BioconThe company said it does not expect the CRL to impact the timing of the launch of biosimilar Pegfilgrastim in the US market.
10 Oct, 2017, 02.19 PM IST
Big boost for Biocon as USFDA Onco committee approves company's first breast cancer biosimilar drugThe USFDA's Oncology Drugs Advisory Committee voted 16-0 in support of the eligible indications of the original product.
14 Jul, 2017, 08.38 AM 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
Biocon climbs 3% as USFDA accepts BLA for Mylan’s anti-cancer drug“This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months”, said Rajiv Mali...
17 Feb, 2017, 10.25 AM IST
US FDA accepts Biocon-Mylan biosimilar application for proposed anti-cancer bio-similarBiocon said that the FDA's acceptance for review of this biosimilar is an outcome of the company’s strong R&D and manufacturing capabilitie...
16 Feb, 2017, 08.28 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 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
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