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Biosimilars

FDA approves first biosimilar for cancer

FDA commissioner Scott Gottlieb said that bringing new biosimilars to patients was an important way to help spur competition that can lower healthcare costs and increase access to important therapies.

The US Food and Drug Administration (FDA) has approved a biosimilar of Avastin (bevacizumab) for multiple cancer indications.

The product, known as MVASI (bevacizumab-awwb), is the first biosimilar to be approved for cancer in the USA.

In 2010, changes introduced by President Obama under the Affordable Care Act created a new, abbreviated pathway for the FDA to license biosimilar or interchangeable products.

FDA commissioner Scott Gottlieb said: “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies”.

The biosimilar monoclonal antibody is approved for multiple indications across five cancer types. All of the indications are already approved for the original product, which was brought to the market by Roche. This includes certain types of metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma and cervical cancer.

The FDA said the evidence it used to approve MVASI as a biosimilar included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data and clinical immunogenicity data, as well as clinical safety and efficacy data.

scott gottlieb rex ss 17

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FDA commissioner Scott Gottlieb said that the administration would continue to bring to the market biosimilar medications that pass the FDA’s gold standard for safety and effectiveness

“We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness,” said Gottlieb.

Biosimilars are products which are highly similar to the original approved product and manufacturers must provide data demonstrating no meaningful difference in clinical safety, purity, potency or efficacy. MVASI, produced by pharmaceutical company Amgen, has been approved as a biosimilar and not an “interchangeable” product, which means that pharmacists cannot substitute it for bevacizumab without the prescriber’s input.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203599

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