Polpharma Biologics and Fresenius Kabi Signal Licensing Settlement for Proposed Vedolizumab Biosimilar PB016

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AMSTERDAM, ZUG, Switzerland & GDAŃSK, Poland — Polpharma Biologics S.A. (“Polpharma Biologics”) broadcasts a world (aside from Center East & North Africa) licensing settlement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio®*), a biologic remedy indicated for reasonable to extreme ulcerative colitis and Crohn’s illness.

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Below the phrases of the settlement, Polpharma Biologics will lead growth and manufacturing of PB016, whereas Fresenius Kabi will maintain unique commercialization rights worldwide, excluding Center East & North Africa.

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“This partnership reinforces our mission to broaden entry to high-quality biologics that enhance affected person outcomes globally,” mentioned Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group. “Fresenius Kabi’s deep commercialization expertise and dedication to biosimilars make them a perfect companion for bringing PB016 to sufferers worldwide. Collectively, we’re taking an necessary step towards addressing the rising burden of persistent inflammatory illnesses.”

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The settlement builds on Polpharma Biologics’ rising biosimilar portfolio and confirmed growth capabilities. The corporate has beforehand introduced ahead a number of biosimilars — together with ranibizumab and natalizumab — throughout world markets in partnership with main pharmaceutical firms.

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This strategic collaboration strengthens each firms’ commitments to increasing world entry to inexpensive biologic medicines whereas supporting healthcare system sustainability.

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*Entyvio® is a registered trademark of Takeda.

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About Polpharma Biologics:

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Polpharma Biologics is a global biotechnology firm with built-in operations within the European Union (EU), growing and manufacturing biosimilar medicines. Utilizing patented options and state-of-the-art platform applied sciences, Polpharma Biologics develops biosimilar merchandise to deal with a variety of circumstances in main therapeutic areas.

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Packages at Polpharma Biologics begin in cell line growth and transition by technical and medical growth to commercial-scale manufacturing getting ready medication for future industrial partnerships with world pharmaceutical organizations. The experience of Polpharma Biologics lies within the growth and manufacture of medicines based mostly on microbial and mammalian expression programs. With its cell line growth middle within the Netherlands and two facilities of growth and manufacturing in Poland, Polpharma Biologics creates development and growth alternatives for biotechnology specialists.

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Be taught extra at

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www.polpharmabiologics.com

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About Fresenius Kabi:

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As a part of the worldwide healthcare firm Fresenius, Fresenius Kabi makes a speciality of (bio)prescribed drugs, medical applied sciences and diet merchandise for vital and persistent circumstances. The corporate’s merchandise, applied sciences, and companies are used for the remedy and care of critically and chronically ailing sufferers. With greater than 41,000 workers and current in over 100 nations, Fresenius Kabi’s expansive product portfolio focuses on offering entry to high-quality and lifesaving medicines and applied sciences. For extra data, please go to

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Necessary Notice

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This press launch is for informational functions solely and doesn’t represent promotional materials for PB016 in Poland or some other jurisdiction. The commercialization of proposed vedolizumab biosimilar PB016 is solely the duty of Fresenius Kabi, the advertising and marketing authorization holder, in accordance with all relevant legal guidelines and rules.

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Disclaimer

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This press launch is issued from Polpharma Biologics Group and is meant to offer worldwide data to healthcare professionals, media and (potential) buyers about our world enterprise in relation to drug growth and manufacturing experience. Though Polpharma Biologics Group shouldn’t be a public firm as of this date, recipients ought to perceive that this press launch incorporates sure forward-looking statements (as outlined within the U.S. Personal Securities Litigation Reform Act of 1995). These statements contain inherent dangers and uncertainties, and precise outcomes could differ materially from these expressed or implied within the forward-looking statements. Components that would trigger precise outcomes to vary materially embody, however usually are not restricted to, the approval and commercialization of the medicinal product, market reception, competitors, modifications in financial circumstances and relevant legal guidelines, world regulatory developments, contractual dangers and dependencies from third events. Polpharma Biologics undertakes no obligation to replace any forward-looking statements to mirror occasions or circumstances after the date of this press launch. Furthermore, Polpharma Biologics needs to emphasise that this press launch is for informational functions solely and shall not be construed as making any illustration, warranties, or ensures, both categorical or implied, concerning the potential approval, market reception, commercialization, or success of the medicinal product or some other product or remedy.

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