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New Biologics Pathway Could Be Daunting for Biologics Developers


Life under the new biologics pathway will be easier for some drugs than others, notes Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.

It will be both interesting and curious to see how drugs fare as they transition to a new biologics licensing pathway under the Biologics Price Competition and Innovation Act (BPCIA), according to Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.

The transition that occurs this week allows certain biologics previously approved as small molecule formulations to be licensed as biologics for the first time. This group includes insulin and human growth hormone.

Some believe the complexity of biologics and the patent thickets that surround their manufacture will present a significant obstruction that hinders competition, although regulators believe the new pathway consolidates protein-based agents under 1 licensing classification and will provide efficiencies and more competition for scarce or prohibitively costly agents, such as insulin.

A Different Status for Basalgar

The Basalgar form of insulin glargine was approved for US distribution in 2015, and it was marketed at a discount to Lantus, the dominant insulin glargine at the time. The follow-on was approved via the 505b(2) pathway for roughly similar existing drugs. Now, Basalgar will enjoy a different type of status under the biologics pathway in the BPCIA.

“It was approved as a follow-on, not a biosimilar, not a generic, and not an interchangeable. Really, when it migrates over, it’s going to be a standalone product,” said Ropka, in an interview with The Center for Biosimilars®. Standalone products are so called because they do not depend on prior approved formulations.

Basalgar will automatically be deemed to be licensed as a biologic under the new pathway, without the burden of needing clinical evidence or going through the approval process, and the independent status may help it to stand out from Lantus.

For novel biosimilars, the process is more complicated, Ropka noted.

The new biologics from the expanded class must be approved under the so-called abbreviated 351(k) pathway of the Public Health Service Act, which enables manufacturers to get their drugs approved “based on a less-than-full complement of product-specific preclinical and clinical data,” according to the FDA.

“First of all, you’re going to have to be approved as a biosimilar, which is a little more rigorous of a pathway,” Ropka said. “And then you’re going to be branded as a biosimilar.”

In some people’s minds, a biosimilar is a lesser medicine than its reference product, so it may not be accepted. “It may not make it onto formularies as readily or it may not be as readily accepted,” Ropka said.

The more fortunate Basalgar will be deemed to be licensed under the 351(a) pathway for the approval of innovator products. “It could become the reference product—oddly enough, for Lantus.”

It is hoped that more insulin products emerge as a result of this new pathway for biologics formerly approved as small molecule drugs, but there may be greater challenges to approval and launch that may be daunting for manufacturers, legal experts have noted. For example, the evidence needed for a biologics application may be more difficult to accrue.

Some Must Do the Patent Dance

Ropka noted that the “patent dance” that has been a feature of most biologics launch efforts will apply also to the newly added group of biologics. In a patent dance, the biosimilar developer and the reference product innovator engage over existing patents that protect exclusivity. This can be a lengthy and costly process that may defeat attempts to bring a product to market or delay its arrival on market by many years.

For chemical-based, small molecule drugs, the patent thicket is much smaller by comparison owing to the less complex nature of these agents, and developers have been aided by the FDA’s Orange Book, which includes exclusivity information along with product formulation data.

For biologics now under the new pathway, “You’re going to have to do your patent dance litigation instead of the Orange Book,” Ropka said.

What may be of some assistance to product developers is the Purple Book, which is an FDA compendium of information on approved biologics. The database has been upgraded to a searchable online database, and the FDA has plans to include exclusivity information, something Ropka said may improve the appeal of bringing drugs to the market under the biologics pathway.

The patent dance “adds another challenge to making a business decision to develop” a biosimilar, she said. However, “clients do use the Orange Book as one bit of information when they’re making their decisions on what molecule to pursue, and I could see a Purple Book patent listing providing the same sort of certainty, Ropka added. “‘This is the universe of patents that I could face. And I can do some early analysis to decide how I feel about facing that patent portfolio.’”

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