Practice Area | Biologics & Biosimilars

Definitions | General Issues | Market Exclusivity Issues | Our Expertise

Definitions of Large Molecules, Biologics & Biosimilars

What is a Large Molecule? The term “large molecule” refers to a biologic medicine derived from living organisms or their components, such as monoclonal antibodies.

What is a Biologic? Biologics are large molecule medicines made from living cells. Their manufacturing processes are far more complex and costly than those of small molecule drugs.

What is a Biosimilar? Biosimilars are analogous to generic drugs for biologics, that is, biosimilars are follow-on products that are approved if they are shown to be “highly similar” to an already approved biologic innovator reference product. Although biosimilars do not have any clinically meaningful differences in safety or efficacy from their innovator, they are not truly bioidentical.

General Issues, Laws & Market Dynamics

The market dynamics for biologics and biosimilars are different from those of small molecule drugs. When a generic small molecule drug enters the market, the price for the drug drops substantially because the market switches to the less expensive generic version.

Rapid market penetration for the generic arises partly because pharmacists are allowed to substitute generics for brand-name drugs, and pharmacists get paid more to fill the generic. The significant drop in overall price translates into savings for the consumer, encouraging greater use of the generic.

The picture is very different for biologics and biosimilars.

Biosimilars are not identical to their innovator drugs, just highly similar. Biologics are often used to treat life-threatening diseases. Accordingly, physicians might be reluctant to switch from the innovator biologic to the corresponding biosimilar. Some have also raised concerns about possible issues with immunogenicity that might not be apparent until several years of use.

Under current laws, in order for pharmacists to substitute biosimilars for innovators, biosimilars must be given an additional designation as “interchangeable.” On July 28, 2021, FDA approved the U.S.’s first interchangeable biosimilar, deeming Semglee (insulin glargine-yfgn) biosimilar to and interchangeable with Lantus (insulin glargine) in the treatment of adults with Type 2 diabetes mellitus and adults and children with Type 1 diabetes mellitus. However, most biosimilars are not filled by a retail pharmacist, because they are administered in a hospital or by a healthcare provider.

Accordingly, the rapid and robust market uptake of generics due to pharmacist incentives that occurred for small molecule drugs likely will not occur for biologics.

Additionally, it is very difficult and costly to make biosimilars compared to small molecule drugs. Accordingly, the price drop associated with a biosimilar coming onto the market will not be as significant as that for a generic small molecule.

Nevertheless, the significant expense associated with some biologics might cause a physician’s practice to consider the biosimilar, particularly for patients just starting treatment.

Market Exclusivity Issues for Biologics and Biosimilars

We have deep expertise in the market exclusivity and intellectual property issues for biologics and biosimilars that arise from the provisions of the Biologics Price Competition and Innovation Act (“BPCIA”).

BPCIA provides a new approach to the patent and regulatory exclusivity provisions that govern the interaction of innovator and generic manufacturers in the Hatch-Waxman Act.

For small molecules, the patent and regulatory issues are linked explicitly through provisions such as Orange Book patent listings and the 30-month stay of regulatory approval following the initiation of a patent infringement suit. However, there are no such patent and regulatory linkages in BPCIA; regulatory approvals can proceed independently of any ongoing patent disputes.

In lieu of the patent and regulatory linkage of the Hatch-Waxman Act, BPCIA provides for a highly complex patent information exchange process and related infringement litigation whose interpretation is still being disputed. In addition, the five-year (new chemical entity) and three-year (new product) exclusivities in the Hatch-Waxman Act have been replaced by a single 12-year reference product exclusivity in BPCIA.

There is no independent exclusivity provided to the innovator for developing new indications/formulations. These differences in patent and regulatory exclusivity provisions have a significant impact on product development strategies for biologics.

Although BPCIA provides for interchangeability exclusivity, only one biosimilar product has been shown to be interchangeable.

Pharmaceutical Law Group Expertise | Leading Authority

Gregory Glover, a registered patent attorney and non-practicing physician with the Pharmaceutical Law Group, is one of the nation’s leading experts on the interaction of food and drug law and intellectual property. Greg’s educational background includes an M.D. from Duke Medical School, a J.D. from Harvard Law School, and an A.B. in Biochemical Sciences from Harvard College.

Dr. Glover has represented pharmaceutical and biotechnology developers, manufacturers, and investors regarding market exclusivity strategies and domestic intellectual property issues. Greg has particular expertise in the patent and non-patent market exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”). He also has expertise in the market exclusivity and intellectual property issues for biologics and biosimilars that arise from the provisions of the Biologics Price Competition and Innovation Act (“BPCIA”).

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