The upcoming inauguration of Donald Trump has left supporters of the current US healthcare system worried, after the President-elect made the repeal of the Affordable Care Act (ACA) of 2010 – also known as Obamacare – a key policy during his campaign.
The Act includes the Biologics Price Competition and Innovation Act (BPCIA), which created a regulatory pathway for biosimilar products in the US. But, according to experts, not only should the pathway be safe from Trump’s pledge, but the burgeoning biosimilar market is likely to blossom under his presidency.
“Although Trump and the Republican party have stated that they want to repeal the ACA which includes BPCIA, it is highly unlikely that the BPCIA is in jeopardy, since recent actions in Congress indicate that the ACA will be re-worked in a piecemeal fashion,” Stacie Ropka, an IP attorney from Axinn Veltrop & Harkrider, told Biopharma-Reporter.
“Given that Trump criticised high drug prices during his campaign, I would expect Trump to favour the approval of biosimilars and so would not be in favour of repealing the BPCIA portion of the Affordable Care Act.”
Ian Platts, a pharmaceuticals markets analyst at BMI Research, took a more cautious approach to biosimilars in the upcoming year.
“Trump's biggest issue in terms of healthcare is likely to be unravelling Obamacare, and whilst there may be legislation introduced as part of this that will have an impact on biosimilars, I think that's likely to be collateral damage,” he told us.
“I don't think in 2017 that biosimilars will be high on the list of issues for state and federal politicians to focus on, either positively or negatively.”
He added there may be indirect consequences from any changes Trump makes at the US Food and Drug Administration (FDA), but believes the biosimilar sector is still too small an issue to be the focus of specific legislation.
“However, the market is likely to continue to grow over the course of the next four years and that will inevitably draw attention. But even then, in terms of products it will still be miniscule compared to biologics, simpler pharmaceuticals and generics.”
FDA filings, approvals and product launches
Both Platts and Ropka agreed last year’s spate of filings with the FDA and subsequent approvals will continue.
“As more biologics are approved by FDA, I would expect more biosimilar applications to be filed,” Ropka told us. “And, as FDA gains confidence in its ability to determine biosimilarity, I would expect an increase in biosimilar approvals.”
Platts added: “There are a number of applications that have been filed over the last 12 months, and I would expect most of these to be approved in the coming year.”
Possible approvals to look out for over the coming year, include a version of Roche’s Avastin (bevacizumab) made by Amgen, Mylan’s version of Herceptin (trastuzumab) and Samsung Bioepis’s infliximab.
However, Platts said the “biosimilar progress will be slowed by ongoing litigation, as happened in 2016, which will be used to flesh out how the biosimilar approval process works.”
As of December 2016, just Amgen’s Zarxio and Pfizer’s Inflectra were available to US patients. Amgen has stated its approved Humira biosimilar Amjevita is unlikely to launch in 2017 due to ongoing litigation with reference drugmaker AbbVie.
Interchangeability
But what will continue to hinder the biosimilar market is the lack of FDA guidance on interchangeability.
The FDA planned to publish interchangeability guidance in 2016, but this now looks like it will be pushed to December 2017 at the earliest, Ropka said.
Platts was more positive, expecting industry pressure to lead to at least draft guidance issued in 2017.
“At the moment, none of the biosimilars so far approved are interchangeable,” Platts added. “This effectively means that as things stand, biosimilar are essentially a new class of drugs, sitting somewhere between an innovative product and a generic equivalent.
“They cannot directly compete with their reference product, or with other biosimilar equivalents. Until this issue is addressed, the biosimilar market will not be truly viable in the way the simple molecule generic drug market is.”