Biosimilars: Technical and Regulatory Challenges Featured Report

15-4-FR-Coverby Cheryl Scott, Senior Technical Editor, BioProcess International

At least one innovator company has embraced the concept of biosimilars wholeheartedly, calling it “our next chapter in healthcare” in a 2016 report. That publication cites product characterization, preclinical studies, nomenclature, reimbursement, and regulatory pathways as the primary challenges facing companies in biosimilar development. (Note: See Amgen’s 2017 biosimilars report here.) For our own featured report on biosimilars this month, we asked the contributors about those topics. The answers below come from Bruno Speder (head of clinical regulatory affairs at SGS) and Mario DiPaola (senior scientific director at Charles River Laboratories).

Product Characterization: What is the most challenging aspect of biosimilar characterization? How are companies obtaining originator samples to compare against?

SPEDER: One major challenge in developing biosimilars is to obtain sufficient originator product for characterization testing in both the preclinical and clinical development phases. The supply of originator product is very closely monitored by the manufacturers of those products because they seek to slow down the development of biosimilars. So this can be a difficult task. Originator product samples usually are obtained through specialized distributors.

Preclinical Studies: Can nonclinical/animal studies aid in supporting extrapolation of indications?

SPEDER: With biosimilars, we need not reestablish the safety or efficacy of a product. That has been established for the reference product. Our goal is to demonstrate that a biosimilar is sufficiently similar to the reference product that it will have no clinically meaningful differences. Extrapolation to indications for which the originator product is approved for market usually is based on clinical evidence.

Nomenclature: How could a lack of clear naming standards affect pharmacovigilance monitoring down the line?

SPEDER: A draft guidance released by the FDA in August 2015 recommends that nonproprietary names for biologic products should consist of a “core” name of the with a unique four-letter suffix. Under that draft guidance, original biologics and biosimilar versions will have the same core names but different suffixes — and thus distinct nonproprietary names. This is just a draft guidance, however.

Currently biosimilars are not considered to be interchangeable with originator products. Because of that, their naming takes on paramount importance in prescribing accurate drugs. Precise naming convention also will assist in clear identification of each individual biosimilar for monitoring adverse events specific to it.

Reimbursement: How do the difficulties with nomenclature affect reimbursement? Are pharmacy-benefit managers a help or hindrance?

DIPAOLA: Currently there isn’t a well-defined reimbursement framework for biosimilars. Unless this is addressed swiftly and correctly, it is likely to undermine the sustainability of this new market. Assignment of the same CMS J code to all biosimilars, when the products can be quite different in their approved clinical indications, is misleading to patients, payers, and physicians. This policy also can lead to situations in which adverse events associated with specific products cannot be unambiguously distinguished or tracked.

Interchangeability is another major issue that adversely affects prescription and reimbursement for biosimilars. In the European Union, interchangeability has been left to the decision of each member state. In the United States, a new guidance was introduced by the FDA in January 2017 to provide recommendation for interchangeability approval.

(See more from Mario in an upcoming “Elucidation” column, part of a regular BPI issue this fall.)

Regulatory Pathways:  Where do the main questions remain — geographically and technically?

SPEDER: It’s a combination of both. The technical challenge is to develop a biosimilar that is similar enough. The geographical challenge remains to satisfy the requirements of each health authority.

Read more about these topics and more in my featured report in BioProcess International’s April issue: Biosimilars — Tackling the Technical and Regulatory Challenges.

Author: bpimagazine

BioProcess International™ is a monthly, controlled-circulation magazine devoted to the development, scale-up, and manufacture of biotherapeutics and biodiagnostics. Each issue provides the global industrial biotherapeutic community with up-to-date, peer-reviewed information detailing the business, politics, ethics, applications, products, and services required to successfully drive biopharmaceuticals, vaccines, and biodiagnostics through the development and manufacturing process. BioProcess International™ is part of Informa, plc, a leading international provider of specialist information and services for the academic, professional and business communities. Informa offers a world-class portfolio of publications, events and data services for researchers, students, lecturers and professionals in the academic and scientific communities worldwide.

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