Catalent and Valerius Link on Biosimilars
US drug development specialist Catalent Pharma Solutions and Valerius Biopharma, a Swiss biopharmaceutical company providing interchangeable treatment options for high-priced orphan and non-orphan biologics, have announced plans to collaborate on the development and manufacture of Valerius’ biosimilar products.
Under the arrangement, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages at its biologics manufacturing facility at Madison, Wisconsin.
The project will utilize Catalent’s proprietary GPEx technology, which the company said creates high-performance, highly stable, production cell lines in a wide variety of mammalian host cells. To date, Catalent claims to have created more than 460 different monoclonal antibodies and monoclonal antibody fusions and manufactured more than 50 different recombinant proteins using the GPEx system.
Valerius Biopharma specializes in developing biosimilar products as alternatives to high-priced biologics in indications where there is a substantial medical need. The company’s product pipeline currently comprises four biosimilar products in different development stages.
Catalent’s Madison site, opened in April 2013 and recently expanded, provides development, manufacturing, and analytical services for new biological entities and biosimilars. The facility was designed for flexible cGMP production from 10 liters up to 4,000-liter scale, and non-GMP production up to 250-liter scale.
FDA’s first biosimilar approval of 2018 is Retacrit
In other news, the US Food and Drug Administration (FDA) has approved its first biosimilar of 2018, Pfizer’s Retacrit. The drug based on epoetin alfa-epbx is a biosimilar to Epogen/Procrit (epoetin alfa) recommended for treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.
Retacrit is also approved for use before and after surgery to reduce the likelihood of red blood cell transfusions being needed due to blood loss.
With the approval, “the FDA is delivering on its promise to increase momentum around biosimilar approvals,” Rick Lozano, vice president of Biosimilars & Integrated Business Development at AmerisourceBergen, commented to the US trade journal Fierce Pharma.
Lonzano said biosimilars are making “great strides” in the US, mostly from positive changes to policy and reimbursement.
While there are still challenges, he said the latest approval “is encouraging as it builds on the success and learnings of past launches.”
Biosimilar producers have improved their marketing skills, but the executive said these drugs need to be distributed in all channels to ensure adequate patient access, and providers need to be educated on the safety and efficacy of the product. He believes significant cost savings are possible if the FDA enacts policies that speed up the process of bringing biosimilars to market.