Vedolizumab biosimilar(Polpharma Biologics S.A.)

AMSTERDAM, Feb. 21, 2024 /PRNewswire/ -- Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio®* (vedolizumab). Results came from a single-dose, randomized, double-blind, 3-arm parallel-group study assessing the PK/PD and immunogenicity for PB016 compared to Entyvio®* after intravenous administration in 120 healthy subjects. PB016 was found to show comparability to Entyvio®* in all investigated PK and PD parameters, with no immunogenicity or safety imbalances to the reference drug. "We are excited to share new data showing the PK/PD comparability of our investigational vedolizumab biosimilar to its reference drug. The results confirm its potential as a more affordable future option for 3.5 million patients suffering from inflammatory bowel diseases in Europe and in the US. As the frontrunner among biosimilar competitors, PB016 targets a market with over $5.3 billion in annual Entyvio®* sales, expected to grow to over $7 billion by 2030", said Konstantin Matentzoglu, member of the Supervisory Board and the executive management, Polpharma Biologics Group. "With two biosimilars from our pipeline already partnered with highly reputable companies, we are proud that PB016 is the next Polpharma Biologics therapy which has entered late-stage development. Our scientists have developed it from cell line development to full-scale manufacturing in-house, an optimal position for securing future commercial partnerships for this asset." Polpharma Biologics is currently conducting a global clinical safety & efficacy study in patients with ulcerative colitis (UC) to provide further evidence on the efficacy, safety and immunogenicity of PB016, as compared to the reference drug. Vedolizumab is a monoclonal antibody that targets the α4β7 integrin, a protein found on gut homing T helper lymphocytes, reducing gastrointestinal inflammation.[1] It is approved in the US and Europe as a treatment for moderate-to-severe cases of UC and Crohn's disease[2],[3] - the two most common forms of inflammatory bowel disease (IBD) - and additionally for pouchitis in Europe.3 Vedolizumab is approved in over 70 countries worldwide, including Japan, Canada, and Australia, though its approved uses may vary. These chronic bowel conditions affect over 3.5 million people in Europe and the US, often significantly impacting patients' daily functioning and quality of life.[4] Factors like genetics and increasing urbanization may be contributing to growing prevalence of these diseases.[5] Polpharma Biologics is focused on broadening access to biological medicines used to treat some of the world's most impactful diseases across neurology, immunology, and ophthalmology. The company is at the forefront of the next wave in biopharma, leveraging its knowledge, capabilities, and footprint to develop its robust pipeline of more than seven biosimilars in early-late-stage development. *Entyvio® is a trademark of Takeda Pharmaceutical Company Limited. About Polpharma Biologics Polpharma Biologics is an international biotechnology company, with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Under partnerships agreements, the company manufactures two approved biosimilars from its pipeline; ranibizumab and natalizumab. With its cell line development center in The Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates development opportunities for biotechnology specialists. Learn more at . Disclaimer This press release is issued from Polpharma Biologics Group B.V. and is intended to provide worldwide information about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group B.V. is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks, and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either expressed or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy. References [1] National Institute for Health and Care Excellence. Available at: . Last accessed February 2024 [2] Entyvio (vedolizumab) US Prescribing Information. Available at: . Last accessed February 2024 [3] Entyvio (vedolizumab) SPC. Available at: . Last accessed February 2024 [4] Jairath V, Feagan B G. Lancet. 2019; DOI:(19)30358-9 [5] GlobalData Epidemiology Forecast to 2031 SOURCE Polpharma Biologics

Takeda’s Entyvio generated Y936.1bn ($6.2bn) in the first nine months of 2023, as per Takeda’s Q3 financials. Image Credit: Marian Weyo / Shutterstock. Netherland-based Polpharma Biologics has released topline results from the Phase III trial of its biosimilar candidate PB016, showing that the biosimilar is non-inferior to its reference biologic, Takeda Pharmaceuticals’ Entyvio (vedolizumab). Entyvio is an α4β7 integrin targeting monoclonal antibody that helps in reducing gastrointestinal inflammation. It was approved to treat inflammatory bowel disease (IBD), namely ulcerative colitis (UC) and Crohn’s disease, by the US Food and Drug Administration (FDA) in 2014. The therapy generated Y936.1bn ($6.2bn) in the first nine months of 2023, as per Takeda’s Q3 financials. The Phase III trial evaluated the efficacy, safety and immunogenicity of PB016 in comparison with Entyvio in 120 healthy participants. PB016 was comparable to Entyvio across pharmacokinetic and pharmacodynamic parameters. Furthermore, there were no immunogenicity or safety imbalances between the two therapies. Polpharma is also investigating PB016 in a Phase III trial (NCT05771155) against Entyvio in UC patients. The study is expected to enrol 750 participants and will conclude in September 2025, as per ClinicalTrials.gov . The IBD market is predicted to grow in the next decade, and GlobalData estimates that the Crohn’s and UC markets will be worth approximately $14.9bn and $11.2bn by 2032. The global sales of Entyvio are projected to reach $7.9bn by 2029, as per GlobalData’s market analysis. See Also: Modakafusp alfa by Takeda Pharmaceutical for Metastatic Melanoma: Likelihood of Approval GlobalData is the parent company of Pharmaceutical Technology . Takeda has also invested in sustaining and increasing revenue generated by Entyvio. The company developed a subcutaneous formulation of the monoclonal antibody, which was approved by the US FDA as a maintenance therapy to treat moderately to severely active UC in adults following induction therapy with intravenous Entyvio in September 2023. Another biosimilar developed by Polpharma is Biogen ’s Tysabri (natalizumab) biosimilar, Tyruko. The biosimilar is licensed to Sandoz , which bears responsibility for distribution and commercialisation. Tyruko was approved by the FDA for all multiple sclerosis (MS) settings where Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease in August 2023.