Table of Contents
This issue of Vital Signs, released on June 2, 2014, discusses the latest strategy surrounding mega deals in the pharma/biotech industry, Eurofins agreement to acquire ViroCor-IBT Laboratories, Qiagen's acquisition of BIOBASE, and the FDA's latest announcement on regulatory requirements for biosimilars.
FDA breaks silence on biosimilars with long-awaited proposal
Source: FierceBiotech, May 14, 2014
In a non-binding draft guidance, the agency spelled out four tiers of possible similarity between an under-review treatment and the approved biologic it hopes to replace. In the best-case scenario, biosimilar developers would need only targeted animal or human studies to prove their drugs match their references, while those deemed not similar would no longer be considered without changes to their manufacturing processes. The FDA’s latest announcement explains how the agency will require drugmakers to submit analytical data comparing biosimilar candidates to their forebears. Depending on what differences those analyses find, the FDA will file each submitted treatment into one of four categories:
- Highly similar with fingerprint-like similarity, in which a submission is deemed nearly identical to its reference product, “based on integrated, multi-parameter approaches,” according to the FDA. Such drugs would need only “targeted and selective” further study to demonstrate their biosimilarity.
- Highly similar, which also meets the statutory standard for similarity but falls short of the above-mentioned gold standard.
- Similar, a label that applies to drugs whose analyses were inconclusive, demanding further data or studies to figure out whether changes in manufacturing or formulation might help demonstrate similarity.
- Not similar, the draft’s most self-explanatory tier, applies to products that don’t measure up to their references.
The Analyst’s Perspective by Steven Atkinson, Senior Industry Analyst,
Life Sciences, North America
It has been four years since Congress authorized the agency to define an appropriate approval pathway for biologic copies in hopes to reduce the biologics healthcare cost. With 40 biosimilar programs in Phase 3 trials, the FDA was forced to deliver some type of clarity. Ongoing clinical research on potential pipeline products; patent expirations of various matured biologics such as Neupogen, Humira, and Lantus; and the increasing demand for the first-wave biosimilar products such as somatropin, filgrastim, and erythropoietin, will help lower the biological product prices. The FDA had to act, but as usual, it is not at lightning speed. These four segmentations are out for public discussion until August 12, 2014, and then it is back to the committee. Meanwhile, the US multibillion-dollar market for biosimilars remains on hold as the FDA discusses its rules. The eventual approval of biosimilars will hopefully decrease the biologics by at least half, similar to how generic affects the pharmaceuticals. The European Medicines Agency has already authorized the approval of 18 biosimilar drugs. The FDA is one of the last agencies to finalize guidance on biosimilars.
Regulatory guidelines for biosimilars have been adopted in over 60 countries to date, but global harmonization of requirements for approval remains a future ideal, rather than a reality. “Biosimilar manufacturers face many challenges, such as upfront manufacturing costs, demonstrating biosimilarity, designing clinical trials to meet ever-changing regulations, assuaging physician concerns about comparability to the original brand, and product differentiation. We are still a long way from global harmonization, so it is critical to understand the regional differences within the competitive and regulatory landscape,” said a senior executive of a pharmaceutical manufacturer.
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