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Biosimilars – Update from ACR 2014

November 17 2014 4:36 PM ET via RheumReports RheumReports

A generic medication is one that is similar enough to the original to be considered the same. Generic medications are cheaper to develop and can be substituted in place of their brand name counterparts. 

A biosimilar is defined as being "highly similar" to the reference product notwithstanding minor differences in clinically inactive components. Biosimilars have no clinically meaningful differences from the reference product in terms of "safety, purity, and potency." 

Applying the principles for generic medications to biologics is a good goal but biologic agents are more complex molecules, making manufacturing processes inherently more difficult and ultimately more expensive. As a result, biosimilars may not be as cheap as one would hope. Furthermore, will biosimilars be substitutable? In order to be substitutable, regulatory agencies (e.g., the FDA) want to know that the risk of switching to the new product will not result in changes in efficacy and safety.

Regulatory agencies are evaluating biosimilars via the following parameters: (1) structural analysis, (2) functional analyses (bioassays) in an in vitro or cell based system, (3) animal toxicity studies, and (4) human clinical studies including pharmacokinetic studies, clinical immunogenicity, and clinical safety and effectiveness. There will also be significant post-marketing commitments especially for safety surveillance. 

Currently infliximab, rituximab, etanercept, and adalimumab biosimilars are under development around the world. Inflectra and Remsima are infliximab biosimilars currently approved in Canada and some EU markets. RCTs have demonstrated comparable quality, safety and efficacy profiles to infliximab in AS (PLANETAS Phase 1 study of 250 patients) and RA (PLANETRA Phase 3 in 606 patients).

Health Canada has approved Inflectra and Remsima as Subsequent Entry Biologics (SEBs) and agreed to extrapolate the data to psoriasis and psoriatic arthritis but not to IBD. The European Medicines Agency (EMA) has extrapolated the data from PLANETAS and PLANETRA to RA, AS, PsA, PsO, and IBD. Inflectra has been submitted to the FDA for approval.


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About the Author

Dr. Andy Thompson
Dr. Andy Thompson

Dr. Andy Thompson is an Associate Professor at Western University and founder of Rheuminfo.com, Rheumtalks.com, and RheumReports.com.

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