Biosimilars
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Pfenex is uniquely situated to deliver a robust pipeline of biosimilars and vaccines to patients globally. We are committed to working with regulatory agencies, legislators and our partners to create and foster a supportive regulatory environment that ensures patient access to needed therapeutics and vaccines.

Naming

To support the use of biosimilars in the U.S., it is our position biosimilars should be given the same INN as the reference product. The current proposal from the FDA to add a suffix to traditional INNs stands to slow growth of the biosimilar market, stifle cost-reduction opportunities, and reduce patient access. We have compelling examples to demonstrate the case for same names – both the Europe biosimilar markets have successfully used the same INN for years and continue to maintain high standards of drug tracking and patient safety. Just recently, 21 leading industry and patient care groups – including CVS Health, Express Scripts, Kaiser Permanente, Pharmaceutical Care Management Association, and Rite Aid – as well as the Federal Trade Commission (FTC) also expressed their support for a system that supports the same INNs for biosimilars and the reference product.

Coding

It is our position that the decision to group all biosimilars to a single reference product under the same Healthcare Common Procedure Coding System (HCPCS) code, with the reference product maintaining a separate code does not support the development of a robust biosimilars market. We remain concerned that the current proposal will hinder biosimilar uptake and discourage innovation by not establishing a reimbursement model for biosimilars based on a product’s unique average sales price (ASP). As defined by the U.S. Food and Drug Administration (FDA), biosimilars are proven to have no clinically meaningful difference in safety, purity, and potency from a reference product. Because biosimilars are comparatively developed to a given reference product, rather than other biosimilars, it is illogical to tie reimbursement to other molecular entities to which the biosimilar was not initially compared. As such, we believe each product should have an individual HCPCS code, which is in accordance with the Biologics Price Competition and Innovation Act (BPCIA). It is our believe that such a policy will better ensure innovation and drive market entry, ultimately allowing the U.S. to realize the full promise of biosimilars.

See below for links to some of our recent positions:

Statement on FDA Release of Draft Interchangeability Guidance
Statement in Response to Final FDA Guidance on Nonproprietary Naming of Biological Products
Statement on Introduction of CREATES Act to Support Access to Reference Product
Statement on Inclusion of Section 11, Biological Product Innovation in the FDA & NIH Workforce Authorities Modernization Act
Statement on the FDA Approval of Celltrion’s Infliximab Biosimilar
Statement on the FDA Draft Guidance on Biosimilar Labeling
Statement on the FDA Arthritis Advisory Committee Meeting on Infliximab Biosimilar
Statement on Final Coding Rule for Biosimilar Reimbursement under Medicare Part B
Pfenex Supports Action from Bipartisan Senators on Proposed Biosimilar Coding Rule
Pfenex Statement in Response to FDA Proposed Naming Rule and Guidance for Biosimilars

Bringing Biosimilars to Market: Why Naming and Coding Matter

Statement from Pfenex on H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015
Pfenex Statement on Amgen v. Sandoz

BSN Letter on Biosimilars Naming June 2015
Compounding: BIO Comments on Pharmacy Compounding Under Section 503A
Vaccines: Lack of Preparedness to Ebola is Symptom of Larger Disease
Informal Coalition on Biodefense and Public Health Preparedness