A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG

On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this updated post, we highlight a German company, Formycon AG, which has eyes on the US marketplace.

Formycon acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Carsten Brockmeyer, PhD, has extensive experience in the biosimilar field, previously helping Hexal Biotech to develop EPO and filgrastim biosimilars for the European market.

Why you may be hearing more about this company: Formycon has two principal biosimilar targets, ranibizumab and ustekinumab. The company disclosed that “it successfully completed a Type IV pre-submission meeting with the US Food and Drug Administration (FDA) in December 2018 and clarified other pivotal issues. The filing with the FDA for the approval of FYB201 is expected at the beginning of the fourth quarter of this year.” A filing for the European Medicines Agency is planned for 2020. A phase 3 clinical trial of this agent was completed in June 2018. In the development of this agent, Formycon partnered with Bioeq GmbH, but it is unclear whether a marketing partner exists for a possible US launch.

The patent for ustekinumab (Stelara®) expires in 2023 (US) and 2024 (Europe). It is partnered with Aristo Pharma GmbH on the manufacture and testing of this interleukin 12/23 inhibitor (also known as FYB 202).

Formycon is in the early stages of developing a phase 3 trial for its biosimilar version of Eylea® (aflibercept or FYB 203), the next generation of macular degeneration treatment. It is partnered with Santo Holding GmbH on the development of aflibercept.

In other biosimilar news… Amgen decided to pull its EMA application for its infliximab biosimilar, likely due to market competition. The company has not taken similar action with regard to an FDA application for the same product, ABP 710. Considering that neither Samsung Bioepis or Pfizer failed to gain traction in the US marketplace for infliximab, Amgen must think that some biosimilar infliximab marketshare growth in the US is still possible.

A Profile of a Lesser-Known Player in the Biosimilar Space: Pfenex

On occasion, we profile some biosimilar manufacturers with whom our readers may not be as familiar as the big pharma players. In this post, we highlight a San Diego company, named Pfenex (pronounced FEE-nex, as in the city).

Pfenex was founded in 2009, the result of a spin-off from The Dow Chemical Company, whose business was based on its proprietary protein production platform. Called Pfenex Expression TechnologyTM, “it combines an extensive toolbox of expression components with a robotically-enabled high-throughput parallel strain screening technology, delivering unprecedented speed and success in identifying protein production strains capable of producing large amounts of soluble, actpfenex-254_(2)[1]ive product,” according to Pfenex’s website.  The company believes that use of this recombinant protein production platform could enable the avoidance of process related intellectual property that challenge other biosimilar manufacturers.

The technology itself was developed in 2001. Patrick Lucy, the Interim Chief Executive Officer, President and Secretary, and Chief Business Officer, has been with the company and its predecessor from the beginning of the platform development. Pfenex is also a founding member of the Biosimilars Council.

Why you may be hearing more about this company: A biosimilar version of ranibizumab (Lucentis®) and a therapeutic equivalent to teriparatide (Forteo®)  are lead products for Pfenex. Teriparatide, although a recombinant protein, is being developed via the 505(b)(2) pathway and the pivotal study is ongoing. Ranibizumab has completed a phase 1/2 trial and according to Mr. Lucy, Pfenex “is considering its strategic options” with regard to advancing the product. Both were produced using its Pfenex Expression Technology, and Pfenex is further leveraging its platform for the development of other products. In 2016, Pfenex completed a $181 million multiproduct partnership with Jazz Pharmaceuticals, which includes an option for Jazz to negotiate a license to Pfenex’s pegaspargase (Oncaspar®) biosimilar candidate.

Interestingly, Pfenex is also using its technology to develop a very different drug candidate, Px563L, a novel recombinant protective antigen-based vaccine to protect against anthrax. This is part of a $143.5 million advanced development contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).