Momenta, BioFactura team up on biosimilars
- Maryland-based biomanufacturing and R&D company BioFactura has inked a non-exclusive license agreement with biosimilars company Momenta Pharmaceuticals to manufacture an undisclosed biosimilar.
- BioFactura will develop a cells line to produce the biologic, using its NS0-based StableFast biomanufacturing platform.
- Momenta has the right to gain an exclusive license for BioFactura's StableFast technology for clinical development and the commercial manufacturing of the drug.
Getting biosimilars right at the manufacturing stage is vitally important, as there must be no clinically meaningful differences between the follow-on biologic and its reference product. Even small changes to cell lines can lead to major changes in how a biologic behaves, including its safety, efficacy and ability to trigger immune reactions. Creating an alliance with a biomanufacturing company before the biosimilar goes to market improves the chance of seamless transfer from preclinical- and clinical-scale to manufacturing-scale.
Cost is also critical, as compared with small molecule generics, the savings on biosimilars are limited. Therefore, to be competitive, companies also need to keep their manufacturing spend down. BioFactura's simple StableFast platform is designed for rapid creation of stable and productive cell lines for biologics manufacturing, according to the company. The stability, speed and productivity all have potential to keep costs low.
BioFactura CEO and President Darryl Sampey sees the agreement as an endorsement of his company's biomanufacturing platform, and adds: "We look forward to continuing to work with Momenta and the expansion of BioFactura’s efforts in biosimilars development."
Momenta has a number of biosimilars in its pipeline from preclinical and process development to pivotal patient studies. It's lead biosimilar is M923, based on Humira (adalimumab). Humira, AbbVie's blockbuster monoclonal antibody developed to treat arthritis and Crohn's disease, goes off patent in the U.S. at the end of 2016. Momenta will be challenging a number of other companies with Humira biosimilars in development, including Amgen, Novartis, and Samsung Bioepis.
- BioFactura Statement
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