Insights Into Unbranded Biologics | A Managed Healthcare Executive® K-cast

Kareem Karara, Pharm.D., BCPS, CCHP, spoke about unbranded biologics, which are identical the branded products. They are coming on the market amid a growing number of biosimilars.

In a recent Managed Healthcare Executive® K-cast, Kareem Karara, Pharm.D., BCPS, CCHP, statewide pharmacy director for the Georgia Department of Corrections at CorrectRx Pharmacy Solutions, discussed the role of biosimilars and unbranded biologics in improving patient access and lowering costs.

Below is a partial transcript of that K-cast.

You can watch the K-cast here.

Biologics versus small-molecule drugs

Biologics are large-molecule drugs derived from human, animal or microorganism sources, explained Kareem Karara, Pharm.D., BCPS, CCHP, statewide pharmacy director for the Georgia Department of Corrections at CorrectRx Pharmacy Solutions. In contrast, small-molecule drugs are chemical compounds. Examples of common biologics include antibodies, blood products, and vaccines.

An increasing number of health conditions, including hemophilia, rheumatoid arthritis, chronic migraines and cancers, are primarily managed with biologics, and the growing popularity of these drugs has made biologics the fastest-growing segment of prescription drug spending in the United States, Karara said. “Biologics represented 70% of the growth in U.S. drug spending between the years 2010 and 2015,” he noted.

This rapid rise in spending has attracted the attention of payers. In fact, Precedence Research has predicted that in less than 10 years, the global biologics market could almost double in size, from $366 billion in 2021 to $719 billion in 2030.

Enter stage left: unbranded biologics

The market for biologic drugs is no longer the exclusive domain of reference products it used to be, Karara said. “The introduction of a biosimilars approval pathway in 2010 was a game changer. It offered manufacturers an opportunity to create similar therapeutically equivalent medications (for biologics) that were only available as brands.”

More and more biosimilars are competing with reference products, and now, “interchangeable biosimilars” are becoming available. Subject to certain state restrictions, pharmacists can substitute these for more costly reference brands without first having to obtain the prescribing physician’s authorization. Interchangeables provide “an opportunity to substitute and increase adoption of biosimilar medications,” Karara said.

Also promising is the arrival of unbranded biologics. “An unbranded biologic is considered by the FDA to be equivalent to its brand-name biological product because it is the same product” as the one approved under the reference drug’s biologics license application (BLA).

Characteristics of interchangeables and unbranded biologics

Interchangeables can be expected to produce “the same clinical result as the reference product in any given patient,” Karara said. “For products that are administered more than once — chronic therapies —the risk in terms of safety or diminished efficacy in alternating or switching between the product and its reference product isn’t any greater than the risk of using the reference product without switching at all.”

Biosimilars differ slightly from unbranded biologics because biosimilars may have different clinically inactive components, Karara said. However, “there are no clinically meaningful differences between the (biosimilar) and the reference product in terms of safety, purity and potency.” Biosimilars must undergo testing “to demonstrate FDA-defined parameters of clinical similarity.”

Biologics are particularly important for the treatment of autoimmune diseases because they help to counter the development of inflammation that leads to joint pain and destruction. “In rheumatoid arthritis, biologics have added a lot of treatment options to our toolkit,” said Karara.However, the number of unbranded biologics is limited, Karara said.

Switching studies

Although biosimilars are highly similar to reference products, studies have shown that patients are
more likely to switch to a different biologic drug if they were taken off a brand-name drug and placed on a biosimilar of that drug. The reasons are not understood, according to Karara. “Physician and patient resistance to switching biologics constitutes one of the major barriers to their adoption — specifically, biosimilar adoption — despite the cost savings that can be achieved," he said.

Karara is interested in what happens when pharmacists begin switching patients to interchangeable biosimilars. A study presented at the American Society of Health-System Pharmacists’ 2022 Summer Meetings and Exhibition in June suggested pharmacists can help patients stick with one type of biologic, whether it is a reference product or a biosimilar, he noted.

Unbranded biologics and patient support

It's unclear how unbranded biologics will affect patient support programs. How rebate agreements will affect access to unbranded biologics is also unknown. The preferred formulary status manufacturers negotiate for their branded biologics may extend to unbranded biologics, but not to biosimilars, Karara said.