Patent Cliff 2.0: How to Leverage the 351(k) Pathway for Biosimilars

Patent Cliff 2.0: How to Leverage the 351(k) Pathway for Biosimilars

Presently, biosimilars are reaching the market using two different regulatory pathways: the 505(b)(2) and the newer 351(k). More than $198 billion in global prescription drug sales are at risk from patent expirations between 2019 and 2024, according to a  new report from EvaluatePharma. Experts are now warning that the bio/pharma industry is on the brink of a second patent cliff.

These patent cliffs have tremendous impacts on the revenue of big pharma companies, forcing them to find new and innovative ways to cut costs, increase prices or find new profit sources.

The Patent Cliff is Back?

The pharmaceutical industry experienced the first “patent cliff” in 2011 through 2016. During this time period, hundreds of billions of dollars in sales of brand-name drugs—some of which accounted for large percentages of big pharma company sales—lost patent protection.

More than $198 billion in global prescription drug sales are at risk from patent expirations between 2019-2024, according to a new report from EvaluatePharma. Experts are now warning that the bio/pharma industry is on the brink of a second patent cliff.

While experts now warn of a second patent cliff, the first one never really went away after the industry’s initial plunge ten years ago. The industry continues to see patent expirations of numerous leading drugs on a revolving basis, but – as an industry first – this time biologicals are in the mix.

So what does this mean for companies pursuing biosimilar drug applications? What is the regulatory pathway forward?

Presently, biosimilars are reaching the market using two different regulatory pathways: the 505(b)(2) and the newer 351(k).

Comparing the 505(b)(2) and 351(k) Pathways

Fundamentally, the 351(k) pathway concerns products that are regulated as biologics under the BPCIA, while the 505(b)(2) pathway concerns products that are regulated as drugs under the Food Drug & Cosmetic Act (FD&C).  The pathways involve vastly different regulatory frameworks.  The table below summarizes some of the differences between the two. 

Comparing the 505(b)(2) and 351(k) Pathways Fundamentally, the 351(k) pathway concerns products that are regulated as biologics under the BPCIA, while the 505(b)(2) pathway concerns products that are regulated as drugs under the Food Drug & Cosmetic Act (FD&C).

  • What is the 351(k) Pathway?The BPCIA signed into law on March 23, 2010, creating an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an already-approved product, with no clinically meaningful differences in terms of the safety, purity, and potency of the product.
    The BPCIA signed into law on March 23, 2010, creating an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an already-approved product, with no clinically meaningful differences in terms of the safety, purity, and potency of the product. In March 2015, the FDA approved the biosimilar Zarxio (filgrastim-sndz)for sale in the U.S. This approval – the first of its kind under the 351(k) pathway – came nearly 5 years after the pathway was first created by the Biologics Price Competition and Innovation Act (“BPCIA”).

It is important to note that the 351(k) pathway will apply to all new biosimilar applications. While it has less of a track record than the 505(b)(2), it confers many of the same benefits small molecule drugs enjoy – including the much-sought-after period of market exclusivity.

Learn more about the 505(b)(2) and 351(k) pathways or contact us to discuss your next generic or biosimilar project!

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