South Korean-based drug manufacturer, Celltrion, has granted exclusive distribution rights of its trastuzumab biosimilar, Herzuma, to the Mundipharma global network of independent associated companies.
South Korean-based drug manufacturer, Celltrion, has granted exclusive distribution rights of its trastuzumab biosimilar, Herzuma, to the Mundipharma global network of independent associated companies. The rights apply to 7 European nations.
“We are pleased to be partnering once again with Mundipharma on the commercialization of our trastuzumab biosimilar,” said Man Hoon Kim, president and chief executive of Celltrion in a statement. “They have a proven track record of launching biosimilars in Europe, working effectively across multiple healthcare systems and demonstrating local in-market expertise. This alliance enables us to continue to pursue our commitment to delivering effective and affordable medicines which benefit healthcare systems, healthcare professionals and patients.”
Richard Trollope, commercial head of oncology and biosimilars at Mundipharma, added, “Celltrion’s decision to entrust us with a third biosimilar from their portfolio is testament to the insight and experience we have developed from successfully launching [2] previous monoclonal antibody biosimilars. With infliximab [Remsima], we achieved market-leading status in the majority of our markets, and we are already seeing strong market uptake with our newest biosimilar medicine, rituximab [Truxima], across those markets where we have distribution rights.”
The trastuzumab biosimilar was granted marketing authorization on February 9 of this year after receiving a positive opinion and recommendation for approval by the European Medicines Agnecy’s and the Committee for Medicinal Products for Human Use in December 2017. The biosimilar is approved for treatment of HER2-positive early breast cancer in the neo-adjuvant and adjuvant setting, metastatic breast cancer, and metastatic gastric cancer in adults.
Herzuma will not be the only trastuzumab biosimilar on the market in Europe. Samsung Bioepis, another Republic of Korea drug maker, has also received marketing authorization for its own trastuzumab biosimilar. The biosimilar is being commercialized by Merck and will be marketed in Europe as Ontruzant. Both products will compete with the reference trastuzumab, Herceptin, which generated global sales of $7.4 billion for developer Roche in 2017.
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
May 13th 2025Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.
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."
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
Oncology Biosimilars Cut Costs; Diabetes and Other Diseases Could Follow
May 6th 2025Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.