Biosimilars (Generic Biotech Drugs) Receive FDA Guidelines for Accelerated Aproval/Competition Will Be Fierce

The Biologics Price Competition and Innovation Act of 2009 provided FDA guidelines for generic biotech drugs, which are called “biosimilars” or “follow-on biologics.” The Act establishes standards for FDA approval of biosimilars and details ways of handling patent disputes. The Act also grants 12 years of intellectual property protection to biologic drugs, which would significantly extend the life of branded biotech-based drugs. This exclusivity would protect the original maker of a biologic, because a generic competitor would not be able to utilize data from the clinical trials conducted by the original maker until the 12 years had passed and the original patent had also expired.

In February 2012, the FDA published guidelines that promised to speed the entry to the marketplace for generic versions of popular biotech drugs as they reach the end of their patent protection. Companies desiring to receive FDA approval to manufacture biosimilars now have a list of steps they must take. Most important to the speedy introduction of these generics is the fact that manufacturers are now allowed to rely to a large extent on the original clinical trials that were conducted by the manufacturers of the original drugs, despite the fact that the generics will likely be slightly different in biological makeup. Thanks to the guidelines, the FDA approved its first biosimilar in May 2015. Called Zarxio and produced by Sandoz International GmbH, the drug is a copy of Amgen Inc.’s Neupogen for the prevention of infections in patients receiving chemotherapy. However, Amgen immediately launched an extensive legal battle in an attempt to keep the generic off the market.

Biosimilars may eventually have dramatic effects on the biopharmaceutical industry, as competition will ensue and generics will eventually force prices down. A large number of important biotech drugs will soon lose patent protection.

Because biotech drugs (“biologics”) are made from living cells, a generic version of a drug may not be biochemically identical to the original branded version of the drug. In fact, it is likely that it won’t be exactly identical. Therefore, they are described as “follow-on biologics” to set them apart. There are concerns that follow-on biologics may not be as safe or effective as the originals.

In addition, the development of generic versions of biologics is very costly. Initial generic development and factory setup for one biologic can require an investment of hundreds of millions of dollars, compared to only about $10 million for non-biologic generic drugs. This is partly because the multiple steps involved in manufacturing such a drug can be exceptionally complex. This leads to another potential hindrance to launching biogenerics. The original maker of a biotech drug may own extensive patents not only on the drug itself, but on the manufacturing processes or equipment required to make the drug. Such manufacturing patents can be difficult for a would-be maker of a biosimilar to overcome. For example, AbbVie, maker of anti-inflammatory drug Humira, one of the most successful and most profitable biotech drugs in history, at one time held over 100 patents related to Humira, including manufacturing patents. The drug sells in such huge quantities that other firms are extremely anxious to launch biosimilar versions. The first biosimilar generics to Humira were launched in 2023. AbbVie has been resisting competitors that claim the firm is unfairly blocking competition. In an unusual deal, three firms that plan to introduce FDA-approved Humira biosimilars, Boehringer, Amgen and Sandoz (part of Novartis), agreed to delay introducing their versions from 2019 until 2023 while paying licensing royalties to AbbVie.

In the European Union, the first biosimilars were approved in April 2006 by the EMA (European Medicines Agency), the regulatory body responsible for new drugs. The first approved biosimilar was Omnitrope, a generic substitute for growth hormone Genotropin. The second was Valtropin.

SPOTLIGHT: European Biosimilars

A small number of biosimilars approved for the market in the EU. European guidelines for approval of biosimilars include:

1) Comparability studies. The proof or lack of proof of comparability to the original drug will dictate how many new clinical studies may be required.

2) Clinical studies to prove the biosimilar’s safety and efficacy.

3) Nonclinical studies.

4) Continuing safety and efficacy study commitments after the biosimilar is approved and brought to market.

In June 2017, the U.S. Supreme Court ruled to allow biosimilars to come to market more quickly. In the case, the court overturned another court’s ruling in which Novartis subsidiary Sandoz was required to wait 180 days after the FDA approval of the Amgen cancer drug called Neupogen, before it could sell its biosimilar Zarxio. The case sets a new precedent that will significantly shorten the timeline for new biosimilars to reach the market.

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