Hyderabad: Drug makers Mylan NV and Biocon Ltd on Thursday said the European Medicines Agency (EMA) has agreed to review Mylan’s application seeking permission to bring Trastuzumab to Europe.

Trastuzumab is a proposed biosimilar—copycat version of a biotech drug—that they developed together to treat certain types of breast and gastric cancers.

A biosimilar is a complex biological product that follows a different approval pathway compared to chemical drugs.

Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from it.

“The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biologic therapy for the treatment of HER2-positive breast cancer," said Arun Chandavarkar, chief executive and joint managing director of Biocon.

The companies anticipate that this may be the first Trastuzumab biosimilar of the world’s third-largest selling cancer drug to be reviewed by developed market regulator EMA.

If the drug gets approval, Biocon will become the first Indian biotech company to crack a highly regulated market.

“This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (the branch of pharmacology concerned with the movement of drugs within the body) and confirmatory efficacy/safety global clinical trials for trastuzumab," Mylan said.

The pharmacokinetics study had demonstrated that the proposed biosimilar was “bio-equivalent" to the reference drug, the joint statement said. If two products are said to be bio-equivalent, it implies they would be expected to be, for all intents and purposes, the same.

Roche’s subsidiary Genentech Inc. is the innovator of monoclonal antibody (those made by identical immune cells that are all clones of a unique parent cell) trastuzumab, which is used primarily in the treatment of HER 2 positive breast cancer. Herceptin had contributed $6.54 billion in global sales for Roche in 2015.

“The acceptance of our regulatory submission of our proposed biosimilar Trastuzumab in Europe is another example of the strong progress we continue to make across our broad biosimilars portfolio," said Mylan president Rajiv Malik.

“Following our successful commercialization in India and emerging markets, we look forward to our pending launch in Europe," he added.

Biocon and Mylan market ‘CANMAb’ and ‘HERTRAZ’ as biosimilars of Herceptin in India. In 2009, Biocon partnered with Mylan to develop six biosimilar products, including trastuzumab.

Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20% to 30% of primary breast cancers are HER2-positive.

Some analysts cheered Thursday’s news, but said the companies may have to wait longer to bring the product to Europe.

“It’s a positive sign, but still a long way before the company actually commercialises the biosimilar," said Hitesh Sharma, national leader of life sciences at EY India.

Sharma said it was difficult to predict the timeline for the review process, adding it takes anywhere between 3 and 18 months as biosimilar approval pathways are new even for regulators, and they will likely have a lot of queries on the trial data.

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