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States Take Action on Biologics

Did you know that the cost of biologics for Rheumatoid Arthritis (RA) can be greater than $60,000 per year?  Some may argue that there are always alternatives to these costly products. But in fact, RA biologics are not first or even second choice drugs to treat the disease. In cases patients need these types of medications that are life altering. What price would you pay to have mobility – to play with your pets, to pick-up you grandchild, or to even leave your home? 

Due to the nature of positive therapeutic outcomes for patients and being big ticket items, there is a great need to manage these drug products. Federal and state governments are concerned about access to these life altering products. Patient out-of-pocket cost, as well the Medicare costs, are placing a huge financial burden at all levels – even with manufacturer discounts and drug plan copays. If these drugs are needed by patients, what are the rules of the road to access and costs? And are there generics to biologics to provide the same therapeutic outcomes at a reduced cost? There are not generics but there are biosimilars. 

The FDA’s stance on ‘generics’ vs ‘biosimilars’2:

“…there are important differences between biosimilars and generic drugs.

For example, the active ingredients of generic drugs are the same as those of brand name drugs. In addition, the manufacturer of a generic drug must demonstrate that the generic is bioequivalent to the brand name drug.

By contrast, biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product, except for minor differences in clinically inactive components. Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety and effectiveness.”

As of November 2018, the FDA has approved 16 biologics and only a few are biosimilars products1 in the US market and none with interchangeability status. Interchangeability (no clinically meaningful differences between the biosimilar and the reference product related to safety and effectiveness) has been elusive. This is due to the molecular complexity and unique manufacturing processes associated with biologics. 

To further add to the challenges, state generic substitution regulations cannot be currently used as the FDA has created alternative language for biologics than that of generic (small molecule) medications.  States are or have taken legislative actions to define the use of biosimilars in their jurisdictions. These actions are across a large spectrum that impacts prescribers, pharmacists and patients, and are not consistent state-to-state.  The states are attempting to balance patient access and costs while managing safety concerns.


1https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580432.htm

2https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#interchange