Two of the biosimilars—trastuzumab and pegfilgrastim—are under review by drug regulator European Medicines Agency. Photo: Hemant Mishra/Mint
Hyderabad: Bio-pharmaceutical company Biocon Ltd on Friday said it expects to see its first set of biosimilar products hit the European market by early 2018.
The company, in partnership with Mylan NV, is developing four biosimilars—pegfilgrastim, trastuzumab, adalimumab and insulin glargine—for regulated markets such as Europe and US. A biosimilar is a drug that has active properties similar to the original biological product. Two of Biocon’s biosimilars—trastuzumab and pegfilgrastim—are under review by European drug regulator the European Medicines Agency (EMA).
In the second quarter, EMA agreed to review Biocon’s applications seeking permission for marketing authorization of pegfilgrastim and trastuzumab.
Pegfilgrastim is used to stimulate the level of neutrophils, a type of white blood cells, in cancer patients undergoing chemotherapy, while trastuzumab is used in the treatment of HER2-positive metastatic breast cancer.
“Typically, the time taken by EMA is roughly 12-15 months for review and approval. Thereafter, once we get approval, we have to register country-wise to get marketing approval,” said Kiran Mazumdar-Shaw, chairperson and managing director of Biocon.
“So we look at a timeline of 12-18 months to really start commercializing the product in Europe,” she said.
Mazumdar-Shaw said the firm is also simultaneously gearing up to file for a review of its products in the US as well.
Biocon has indicated it will be filing at least four biosimilar applications for review in Europe and the US.
Adalimumab, the monoclonal antibody of AbbVie Inc.’s Humira, is used to treat rheumatoid arthritis.
The four biosimilars have an addressable market size of $30 billion.
Before regulated markets come into play, Biocon is pushing its biosimilars in emerging markets such as Latin America, Africa, Middle East, Eastern Europe and South-East Asia by entering into licensing pacts with local partners for drugs such as trastuzumab and insulin glargine. “Emerging market opportunities will happen very soon, as emerging market regulatory timelines are much shorter than developed country regulators,” Mazumdar-Shaw said.
“We expect by next fiscal some of the licensing income opportunities will translate into sales,” she added.
The firm said its Malaysian insulin facility has got approval from the country’s drug regulator and will start shipping products from the second half of this year.
The Malaysian facility will help Biocon ease supply constraints, and expand its insulin market in India and other emerging countries.
Biocon’s shares rose 2.61% to close at Rs1,005.85 on BSE, while the benchmark Sensex declined 0.19% to end at 28,077.18 points.