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Why Are We Still Waiting for Biosimilars?

Generic drugs saved around $230 billion for the US healthcare system in 2016. For biosimilars, regulation has been in place for six years but no meaningful societal savings have been achieved, despite the great potential of these medicines. According to the RAND Corporation research institute, biosimilars alone could cut US spending on biologics by $44 billion over the next decade (1).

Something has to give and, despite controversy, the Trump Administration might just prove to be the opening the industry has been waiting for. President Trump has suggested he wants to shake up pharma as part of his pledge to ‘Make America Great Again’. It’s difficult to tell how serious he is on the matter, but if he follows through on his claims then there is reason to believe that the route to market for biosimilars could be easier for manufacturers.

Trump would be wise to consider the latest projections from the Pharmaceutical Care Management Association (PCMA) before making any big decisions; PCMA’s report is not the first to suggest that biosimilars could help finance Trump’s vision (2). The trade association claims its proposals would amount to $100 billion in savings over a decade. Its recommendations include a shortened biologic exclusivity period – seven years instead of the current 12 (the number proposed by the Obama Administration when the biologics approval pathway was set up), which would bring biosimilar rivals to market much earlier.

PCMA has created a website to support its proposals, as well as taking to social media to spread the message. It also claims to have met with “key officials all over Washington” to talk drug prices. A call for greater biosimilar use is just one of the proposals being pushed by PCMA – the association is also calling for an end to requirements for insurance plans to pay for all drugs in certain classes under Medicare, regardless of price.

However, my concern is that the biosimilars sector will continue to be held back by a lack of interchangeability guidance and ongoing litigation. Though the Biologics Price Competition and Innovation Act (BPCIA), which created a regulatory pathway for biosimilar products in the US, looks to be safe from Trump’s dismantling of the Affordable Care Act, biosimilars are not likely to be high on the administration’s agenda. The Generic Pharmaceutical Association (GPhA) is doing its best to present biosimilars as a “ready-made solution” to high drug costs, but new measures are desperately needed to aid their entry into the market. As a starting point, here are three measures that could go a long way towards boosting biosimilars use in the US.

Firstly, implementation of interchangeability. In January, the FDA released its long-awaited draft guidelines detailing the agency’s expectations for demonstrating biosimilar interchangeability. The guidance recommends that sponsors conduct one or more switching studies to demonstrate safety and efficacy in patients alternating between the two products. However, the FDA has stated that requirements will vary based on the nature of the proposed interchangeable product and may include an evaluation of data and information generated to support a demonstration of a biological product’s biosimilarity. In short, we’re in for a long wait before an interchangeable biosimilar comes to market... As I see it, substitution was the key for small molecules and will be for biosimilars, too.

Secondly, launch at approval. Biosimilar approvals are progressing, but significant hurdles remain, even when a biosimilar is proven to be highly similar to its reference product in the shape of stays and patent-linkage. Currently, biosimilar makers must wait six months after winning federal approval to begin selling them – although this may change. The US Supreme Court has agreed to hear a dispute over whether companies must wait that long. Is it right that brand-name manufacturers are given an extra six months of exclusivity on top of the 12 years already provided for under the law, driving up healthcare costs?

Thirdly, pro-generic penetration mechanisms. We need to implement mechanisms that further support generic penetration and allow free competition – it worked for small molecule generics and it will for biogenerics, too. I don’t need to highlight how American brand and specialty drug prices are among the highest anywhere (despite the fact the US pharmaceutical market is the largest in the world). Pro-generic penetration mechanisms would appear to be common sense to anybody looking in.

On that note, Trump has defended some of his policies as “common sense”; I wonder if he intends to apply that to biosimilars, too?

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  1. RAND Corporation, “The Cost Savings Potential of Biosimilar Drugs in the United States”, (2014). Available at Last accessed April 17, 2017.
  2. PMCA, “Biosimilars (2017). Available at: Last accessed April 17, 2017.
About the Author
Robert Wessman

Robert Wessman is Chairman and CEO of Alvogen, USA.

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