Are Biosimilar Drugs Safe?


Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods.

Biosimilars (or follow-on biologics) are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product.[1] Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada.[2]Reference to the innovator product is an integral component of the approval.

Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products can have serious health implications.  (From Wikipedia.)

Hatch, Alexander Call on Burwell to Immediately Release Guidance on Biosimilar Drugs

Say patients, health care professionals, and congress must see FDA’s draft policy on naming, other key issues before first biosimilar is approved

U.S. Senators Orrin Hatch (R-Utah) and Lamar Alexander (R-Tenn.) have led colleagues in calling on the Obama administration to release guidance documents on biosimilar drug approvals. The senators were joined by three Republican members on the Senate health committee, Senators Richard Burr (R-N.C.), Mike Enzi (R-Wyo.) and Pat Roberts (R- Kan.).

In a letter to Health and Human Services Secretary Sylvia Burwell, the senators write: “We write today with concerns about the implementation of the Biologics Price Competition and Innovation Act (BPCIA), bipartisan legislation enacted in 2010 to provide the U.S. Food and Drug Administration (FDA) with a framework to review and approve biosimilars. The FDA has not yet issued guidance on some of the key scientific policy questions related to biosimilars, such as naming, labeling, indication extrapolation, and interchangeability.”

Last week, FDA accepted the first biosimilar application for review, but outside of meetings with individual companies seeking to file applications, has not released any guidance. “These meetings should not be the only or primary means by which BPCIA implementation policies are developed,” the senators write. “Does the FDA intend to approve the first biosimilar before policies on these key scientific questions are publicly released?”

“The public needs to have time to comment and FDA time to revise the policies set forth in this draft guidance if necessary. …It is our understanding that FDA has forwarded the naming guidance to the Department of Health and Human Services (HHS), and this guidance is awaiting HHS’ clearance so it can be released for stakeholder comment.  In order to ensure the success of the biosimilar pathway, it is imperative that the scientific experts at FDA maintain the autonomy to implement the pathway as intended in a manner that puts the safety of patients first.”

The senators urged the immediate release of guidance for review by patients, healthcare professionals, policy makers, and others, saying, “Their participation is necessary before settling on final policies.”