Companies Sign Manufacturing Agreements Aimed at Increasing Biosimilar Access, Affordability

Over the past week, 2 companies have signed agreements aimed at increasing access and affordability to biosimilars in the United States, including a manufacturing agreement that was established in Puerto Rico.

OcyonBio and Biosimilars Solutions Enter GMP Manufacturing Deal

OcyonBio, a company based in Aguadilla, Puerto Rico, announced a manufacturing and operations agreement for the development of facilities that will be used to produce biosimilars with Biosimilar Solutions, Inc.¹

Under the agreement, OcyonBio is creating an advanced therapy contract development and manufacturing organization that will allow Biosimilars Solutions to have access to the full development process for biosimilars, including preclinical testing, clinical trials, and commercial manufacturing. The agreement will ensure that the biosimilars are developed using the current Good Manufacturing Practice (cGMP) regulations that are enforced by the FDA.

“With our partnership development manufacturing organization model, OcyonBio is the perfect partner to usher in these biosimilars to the U.S. Biosimilar Solutions, Inc. will have streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, [European Medicines Agency], and global regulatory audits," said Robert Salcedo, CEO of OcyonBio, in a company announcement.

The Aguadilla-located plant that is included in the deal includes over 95,000 sq ft of cleanroom and biomanufacturing space. Biosimilar production in the facilities is anticipated to begin sometime this year.

Previously, Biosimilars Solutions entered a license and development agreement with Reliance Life Sciences, an Indian biosimilar company that markets overseas. Biosimilars Solutions said that it expects it to create in-house commercial-scale facilities for recombinant proteins and monoclonal antibodies.

“We are excited to start working with OcyonBio in Puerto Rico. There is no doubt the island's capabilities in the bioscience sector will help us meet our goal of making medicines affordable for all,” said Daniel Chang, cofounder of Biosimilar Solutions.

Evio Starts Initiative for Biosimilar Affordability

Evio Pharmacy Solutions announced that it has rolled out a biosimilar strategy that will increase the affordability of biosimilar medications.²

“The high cost of medications for individuals with chronic conditions can be a deterrent for filling and taking medications—we're hoping the introduction and acceleration of high-quality biosimilar alternatives, especially for new patients, will be an appropriate way to get lifesaving medications to high-risk patients in a more affordable way," said Helen Sherman, PharmD, chief transformation officer at Evio.

As part of the initiative, Evio has signed contracts with manufacturers of biosimilars that treat autoimmune diseases and different types of cancer under the medical benefit. The contracted deals will allow for biosimilars to be offered at significant savings.

Additionally, all 5 of the health plans that are invested in Evio, which serve over 20 million members across the United States collectively, have chosen to participate in the initial offering as customers. Evio said that it plans to expand the initiative to other health plans over time.

“When we established Evio, we set out to transform pharmacy….Our work is centered on making it easier for patients to access the medications and treatments they need while reducing costs and improving their medication experience,” said Hank Schlissberg, CEO of Evio, in a statement.

Reference

1. OcyonBio announces biosimilar solutions to begin GMP manufacturing in Puerto Rico. News release. OcyonBio; March 12, 2022. Accessed March 16, 2022. https://www.globenewswire.com/news-release/2022/03/14/2402799/0/en/OcyonBio-Announces-Biosimilar-Solutions-to-Begin-GMP-Manufacturing-in-Puerto-Rico.html
2. Evio Pharmacy Solutions introduces biosimilar strategy to help make high-quality medications affordable. News release. Evio Pharmacy Solutions; March 15, 2022. Accessed March 16, 2022. https://www.prnewswire.com/news-releases/evio-pharmacy-solutions-introduces-biosimilar-strategy-to-help-make-high-quality-medications-affordable-301502361.html