Indian drugmakers Mylan and Biocon are developing six biosimilar monoclonal antibodies for global markets and today announced the first – a version of Roche/Genentech’s breast cancer drug Herceptin – has been submitted to the US Food and Drug Administration (FDA) for review.
The proposed product MYL-1401O was submitted via the 351(K) dedicated biosimilar pathway and includes analytical similarity, nonclinical and clinical data, along with the results of the firms’ Phase III HERITAGE trial showing comparable efficacy and safety with Roche’s reference biologic.
Mylan’s President Rajiv Malik said the candidate “has the opportunity to be the first biosimilar trastuzumab approved in the US” though added the companies’ “trastuzumab biosimilar is already being sold in 11 developing markets, including India.”
Roche spokesperson Anja von Treskow was not able to comment on the submission itself, but told this publication: "In order to ensure the safety of patients, we believe that the development and manufacture of biosimilar monoclonal antibodies must be subject to rigorous clinical and regulatory standards, as well as post-marketing pharmacovigilance protections."
For the nine months ending September 30 2016, Roche clocked in US Herceptin sales of almost CHF 1.9bn ($1.95bn).
In India, the product is marketed by Biocon under the name Canmab and is produced at the firm’s biologics facility in Bangalore. The facility manufactures mAb biosimilars for the collaboration’s global supply, a Biocon spokesperson confirmed.
If approved in the US, the product will be marketed by Mylan, which also holds commercialisation rights for the product in Canada, Japan, Australia, New Zealand and the European Union.
Europe paved the way for a trastuzumab biosimilar when, in 2014, the High Court in London ruled in favour of fellow biosimilar developer Hospira (now part of Pfizer) and revoked two of the mAb’s patents.
Mylan and Biocon successfully submitted its filing of its version of trastuzumab to the European Medicines Agency (EMA) in August this year. Pfizer, at least publically, is yet to have done so.
This is the second regulatory submission the two firms have announced in the past week, having submitted their co-developed insulin glargine product - a version of Sanofi's Lantus - to the EMA for review last Thursday.