FDA Reviews Apotex's Biosimilar To Amgen's Neulasta
By Cyndi Root
Apotex, a large Canadian pharmaceutical company, announced in a press release that the Food and Drug Administration (FDA) is reviewing its biosimilar in comparison to Amgen’s Neulasta. Apotex jointly developed the pegfilgrastim biologic with Intas Pharmaceuticals from India, and the product will be distributed by ApoBiologix, an Apotex division. The company filed for approval under the 351(k) abbreviated approval pathway authorized by the Biosimilar Price Competition and Innovation Act (BPCIA).
Dr. Jeremy B. Desai, Apotex President and CEO, said, "The benefits for patients, payers and providers from biosimilars will be significant. We are dedicated to playing a leading role in the effort to increase the American public's access to more affordable versions of these life-saving therapies and generate substantial savings for the US health care system.”
Neulasta
Amgen’s Neulasta is a formulation of Neupogen (filgrastim), a pegylated granulocyte-colony stimulating factor (G-CSF). The long-acting agent helps cancer patients undergoing chemotherapy to fight infection by increasing white blood cells. Apotex states that sales for the agent were $3.6 billion in 2013. The company states that the FDA’s application acceptance for pegfilgrastim marks the first time that the federal agency has reviewed the long-acting formulation of the product, and this is the agency's third known acceptance of a biosimilar application. The industry will be watching the FDA’s actions on the application for indications on how it will review other biosimilar applications.
About Apotex
Apotex is a large company founded in 1974 that now has over 10,000 employees and yearly sales of approximately CAN $2 billion. The company is based in Canada and has U.S. headquarters in Weston, Florida. Apotex has manufacturing facilities worldwide that produces 300 therapeutics and 24 billion dosages per year that it distributes to 115 countries. The company’s pipeline includes 500 products.
Due to irregularities in manufacturing in India the past year, in September 2014, Apotex issued a press release regarding its manufacturing facilities in India. One facility in Bangalore manufactures raw materials and the other produces finished products. Health Canada officials have inspected both facilities and approved them. Dr. Desai of Apotex stated that imported products are legally mandated to be re-tested at a Canadian facility before distribution, assuring Canadian consumers that products coming from India are safe.