Fresenius Kabi, part of the global healthcare company Fresenius, has entered a licensing agreement with Polpharma Biologics S.A., a developer and manufacturer of biosimilar products, based in Poland. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally, except the Middle East and North Africa, pending approval by respective regulatory authorities.
PB016 is a biosimilar candidate to Entyvio®*, an integrin receptor antagonist used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease.
“Today marks a significant milestone in our journey to provide patients with access to affordable, high-quality biosimilar treatments,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases.”
This agreement builds on Fresenius Kabi’s successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars. This milestone underscores Fresenius Kabi’s commitment to broadening access to essential, high-quality biosimilar therapies. Through this agreement, Fresenius is strengthening its (Bio)Pharma platform, which is a key pillar of the #FutureFresenius strategy.
*Entyvio® is a registered trademark of Takeda.
Fresenius Kabi, part of the global healthcare company Fresenius, has entered a licensing agreement with Polpharma Biologics S.A., a developer and manufacturer of biosimilar products, based in Poland. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally, except the Middle East and North Africa, pending approval by respective regulatory authorities.
PB016 is a biosimilar candidate to Entyvio®*, an integrin receptor antagonist used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease.
“Today marks a significant milestone in our journey to provide patients with access to affordable, high-quality biosimilar treatments,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases.”
This agreement builds on Fresenius Kabi’s successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars. This milestone underscores Fresenius Kabi’s commitment to broadening access to essential, high-quality biosimilar therapies. Through this agreement, Fresenius is strengthening its (Bio)Pharma platform, which is a key pillar of the #FutureFresenius strategy.
*Entyvio® is a registered trademark of Takeda.
Fresenius announced today that the European Commission has granted approval for their denosumab biosimilars Conexxence®* and Bomyntra®* in Europe.
The two approvals cover all indications of the reference products including osteoporosis in postmenopausal women and at-risk men, treatment-related bone loss, prevention of skeletal complications from cancer metastasis to bone, and giant cell tumor of bone.
This milestone marks a significant advancement in Fresenius Kabi’s mission to expand access to high-quality biosimilar therapies. It also reinforces the business’ commitment to strengthening its Biopharma platform, a key pillar of the #FutureFresenius strategy.
*Conexxence and *Bomyntra are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.
Fresenius announced today that the European Commission has granted approval for their denosumab biosimilars Conexxence®* and Bomyntra®* in Europe.
The two approvals cover all indications of the reference products including osteoporosis in postmenopausal women and at-risk men, treatment-related bone loss, prevention of skeletal complications from cancer metastasis to bone, and giant cell tumor of bone.
This milestone marks a significant advancement in Fresenius Kabi’s mission to expand access to high-quality biosimilar therapies. It also reinforces the business’ commitment to strengthening its Biopharma platform, a key pillar of the #FutureFresenius strategy.
*Conexxence and *Bomyntra are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.
Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for its denosumab biosimilar candidates for the treatment of osteoporosis and other bone-related conditions.
The biosimilars are recommended for approval for all indications of the reference products 1Prolia® (denosumab) and 2Xgeva® (denosumab) from AMGEN.
The CHMP positive opinion marks an important step in Fresenius Kabi's efforts to enhance patient access to biosimilar products and expand its capabilities and portfolio in biosimilars development. Developing the company's Biopharma platform is a key element of #FutureFresenius.
1Prolia® and 2Xgeva® are registered trademarks of Amgen Inc.
Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for its denosumab biosimilar candidates for the treatment of osteoporosis and other bone-related conditions.
The biosimilars are recommended for approval for all indications of the reference products 1Prolia® (denosumab) and 2Xgeva® (denosumab) from AMGEN.
The CHMP positive opinion marks an important step in Fresenius Kabi's efforts to enhance patient access to biosimilar products and expand its capabilities and portfolio in biosimilars development. Developing the company's Biopharma platform is a key element of #FutureFresenius.
1Prolia® and 2Xgeva® are registered trademarks of Amgen Inc.
Fresenius today announced that its operating company, Fresenius Kabi, is now offering Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States. Following the introduction of the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers in December 2024, the product launch expands Fresenius’ offerings of Epinephrine Injection.
Epinephrine Injection 30 mg per 30 mL is a prescription medicine used for emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Epinephrine Injection is manufactured in the U.S., reflecting the company’s commitment to domestic production. More than 70% of the pharmaceuticals that Fresenius Kabi sells to U.S. customers are formulated, filled and packaged in the U.S.
Fresenius today announced that its operating company, Fresenius Kabi, is now offering Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States. Following the introduction of the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers in December 2024, the product launch expands Fresenius’ offerings of Epinephrine Injection.
Epinephrine Injection 30 mg per 30 mL is a prescription medicine used for emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Epinephrine Injection is manufactured in the U.S., reflecting the company’s commitment to domestic production. More than 70% of the pharmaceuticals that Fresenius Kabi sells to U.S. customers are formulated, filled and packaged in the U.S.
Fresenius continues reducing complexity and optimizing utilization in the production network of its Operating Company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius: Today, Fresenius Kabi and EMS have signed an agreement to transfer the ownership of Fresenius Kabi's production site in Anápolis, Brazil, to EMS. The multinational pharmaceutical company has a strong presence in Latin America and will take over the generic injectables production plant, the development center, and the warehouse as well as full staff and will continue production.
The transaction is subject to customary closing conditions, including merger approval.
Fresenius continues reducing complexity and optimizing utilization in the production network of its Operating Company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius: Today, Fresenius Kabi and EMS have signed an agreement to transfer the ownership of Fresenius Kabi's production site in Anápolis, Brazil, to EMS. The multinational pharmaceutical company has a strong presence in Latin America and will take over the generic injectables production plant, the development center, and the warehouse as well as full staff and will continue production.
The transaction is subject to customary closing conditions, including merger approval.