Biosimilar entry onto US market slow despite action by FDA, says GlobalData

Biosimilar entry onto US market is slow despite implementation of the Biologics Price Competition and Innovation Act (BPCIA) by the Food and Drug Administration (FDA), according to data and analytics company, GlobalData.

The BPCIA was created to abbreviate the pathway for biosimilar drug approval, however, since its implementation in 2010 there are only nine biosimilars available on the US market. As a result of this slow uptake, the agency is taking proactive measures, such as educating patients and physicians through online resources and information campaigns to encourage more competition and lowered prices of biologics.

A potential educational barrier identified is the recent biosimilar naming system that was employed by the FDA. This naming system requires that biosimilars include the non-proprietary name and a suffix that identifies the manufacturer, which is aimed at improving pharmacovigilance but can result in confusion over clinical effects.

Antoine Grey, MBiochem, pharma analyst at GlobalData, said: “Without a meaningful drive to educate physicians, biosimilars are likely to be dismissed as less effective than their reference products, therefore the financial incentive for entering the biosimilar market is significantly reduced.”

Another potential barrier reducing financial incentive is the tendency of pharmacy benefit managers (PBMs), who despite discounts continue to favour the original product over biosimilars. Even though the initial discounts on biosimilars are around 15–20%, these are offset by the small number of patients choosing the biosimilar over the branded product.

Grey continues: “As a result, biosimilar sponsors are unable to offer large patient volume-based rebates on their products and PBMs therefore try to limit biosimilar uptake so as to maintain rebate payments.”

In addition to these barriers, is difficulty in manufacturing a biosimilar that can be interchangeable with its reference product. If deemed as being interchangeable a biosimilar can replace the reference product at a pharmacy without permission. However, due to FDA draft guidance set out in January 2017, manufacturers may need to perform additional clinical studies to demonstrate interchangeability, something that hasn’t been achieved by any biosimilar to date.

Grey added: “The process is not as simple for biologics, therefore biosimilar manufacturers may struggle to replicate the reference product even with a sample of the biologic.”