The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis.
With the first U.S. biosimilar approval, for Zarxio (filgrastim-sndz) in March 2015, it is still too early to write a “lessons learned” article on the manufacture of molecules formerly known as “follow-on biologics.”
According to the Generics and Biosimilars Initiative, the manufacture of biosimilars is more challenging than for small-molecule generics because investments and operating costs for biosimilars, coupled with the risk of failure, are significantly higher than for generics. Thus the relatively small discount for biosimilars compared with generics. Manufacturers are expected to discount biosimilars by 15 percent to 35 percent, compared with up to 90 percent for small-molecule generics. Still, experts predict that biosimilars could save the U.S. healthcare system as much as $40 billion over the next decade.
As with their reference biologics, biosimilars are complex molecules derived from living cells with inherent variability. Developing biosimilars involves several steps, including the selection of an appropriate reference biologic, understanding its key molecular attributes, and designing a suitable manufacturing process. EMA and FDA guidances require that biosimilars undergo rigorous evaluation for similarity in lieu of conducting extensive preclinical and clinical studies. Demonstrating similarity is an extensive comparability exercise, while achieving and maintaining similarity requires a tightly controlled manufacturing process.
Related on the SLP
“Molecularly, to develop a biosimilar of an advanced biologic, scientists conduct an in-depth analysis of the originator biologic and steadily isolate the critical quality attributes (CQAs) that define the safety and efficacy of the active ingredient,” says Mourad Farouk Rezk, M.D., senior director, global head medical affairs biosimilars at Biogen.
Read full, original post: Biosimilar Manufacturing Challenges
