Livemint: May, 2015
New Delhi: Biocon Ltd said on Thursday that two biosimilar drug molecules developed by it to treat cancer and rheumatoid arthritis had entered global phase 3 clinical trials, which entail testing on patients to assess effectiveness and safety.
The two molecules, pegfilgrastim and adalimumab, were developed in partnership with Mylan NV.
Pegfilgrastim is used to treat cancer. Adalimumab, the monoclonal antibody of AbbVie Inc.’s Humira, is used to treat rheumatoid arthritis. Humira was the world’s largest selling drug in 2014 with sales of around $12.54 billion.
Biosimilars are generic versions of biological drugs that are not possible to copy exactly and require clinical trials to establish that they are safe and effective.
The US Food and Drug Administration (FDA) approved the first biosimilar of filgrastim in March under the biosimilars pathway, established by the 2009 Biologics Price Competition and Innovation Act (BPCIA), paving the way for more biosimilars to hit the world’s largest market for medicines.
Biocon said the phase 3 trial for its breast cancer drug trastuzumab is progressing in more than 100 sites around the world.
Trastuzumab is the biosimilar version of Roche Holding AG’s monoclonal antibody Herceptin, used in the treatment of breast cancer based on HER2-positive subtype gene mutation.
Biocon sells Trastuzumab under brand name CANMAb in India.
The Bengaluru-based company said the initial test of the phase 3 trial for bevacizumab or biosimilar version of Roche’s Avastin is also underway.
Avastin is used in treatment of certain types of cancers.
Biocon said two global clinical trials for long acting generic insulin glargine initiated in 2014, have also made significant progress.
The patient recruitment for a type-1 diabetes study has been completed ahead of schedule, while the recruitment for a type-2 diabetes study is expected to be completed by July 2015, the statement said. “The advancement of these programmes in the clinic represents significant progress towards providing these high-quality biologics to patients across the world,” said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.
Biocon entered into an agreement with Mylan in June 2009 to co-develop biosimilars of monoclonal antibodies and recombinant proteins; again, in February 2013, both companies agreed to co-develop generic insulin analogs.
Under the terms of the deal, Biocon and Mylan will have co-exclusivity in certain markets, such as India; and in other markets, where Mylan has exclusive commercialization rights, profits are shared by both the companies.
Biocon said it plans to spend about 8-9% of its biopharma sales, as its key biosimilar programmes recombinant human Insulin (rh-Insulin), insulin glargine and trastuzumab are in advanced clinical development in phase 3, and are likely to hit the developed markets of US and Europe by 2017-18.
Biocon expects to see its biosimilars contributing about $200 million by 2018-19.
“It would take at least two-three years for Biocon to launch any of these products in the US and Europe,” said Hitesh Mahida, an analyst with Antique Stock Broking Ltd.
Teva Pharmaceutical Industries Ltd has made an unsolicited offer to buy Mylan on 21 April. Mylan rejected the offer.
Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said last week that she did not see any risk to the Biocon-Mylan deal in the event of a Teva’s takeover. There is continuity for all of Biocon’s Mylan programmes whether the deal takes place or not, Mazumdar-Shaw had said.