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Polpharma Biologics Executives Discuss Ranibizumab Biosimilar and Other Product Candidates
The Center for Biosimilars® speaks with Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, about the company's biosimilar pipeline.
Polpharma Biologics, of Gdańsk, Poland, is a rapidly growing developer and manufacturer of novel biologics and biosimilars for global markets. Recently the company filed a biologics license application with the FDA for a ranibizumab biosimilar candidate (FYB201) referencing Lucentis, the blockbuster ophthalmology agent. This was filed in partnership with Santo Holding (Strüngmann Group), Bioeq.
Polpharma Biologics is also developing a natalizumab biosimilar (PB006), referencing Tysabri, for Crohn disease and multiple sclerosis. The company is partnering with Sandoz on the commercialization of this product. Behind FYB201, the natalizumab biosimilar is the next furthest along in development, having reached the clinical development stage.
The global market is still wide open for ranibizumab and natalizumab biosimilars. The only ranibizumab biosimilar approved by US and EU regulatory authorities is Byooviz, a Samsung Bioepis and Biogen product. There are no natalizumab biosimilars on the US or EU markets currently.
In this interview, Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, speak with Tony Hagen, senior editor of The Center for Biosimilars®, about the company’s product expectations and growth.
Moulson and Lewinski also discuss the company’s broader pipeline of products, such as a planned vedolizumab biosimilar (PB016), for the treatment of autoimmune disease, and pembrolizumab and nivolumab biosimilar candidates (PB014 and PB015, respectively), both “programmed death” protein inhibitors that lower the tumor cell’s defense system and allow immune cells to attack.
Polpharma Biologics has added 300 employees over the past couple of years, bringing its headcount to 800. The company, with facilities also in Warsaw, Poland, and Utrecht, in the Netherlands, continues to expand with multiple new job openings. The company has changed rapidly since The Center for Biosimilars® profiled it in 2020.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients Is Crucial for Pharmacists
June 5th 2025Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
