Biosimilar Market Updates

Shanghai Henlius biosimilar antibody developments

On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products Administration (NMPA) for HLX14, a biosimililar to Amgen’s PROLIA (denosumab).  According to the press release, HLX14 is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.  HLX14 has been demonstrated to have high similarity to denosumab in preclinical pharmacology, toxicology, and pharmacokinetic studies.

On March 31, 2020, Shanghai Henlius Biotech, Inc. announced that it has entered into an exclusive license agreement with Mabxience Research, S.L. (“Mabxience”) to  develop and commercialize HLX02, a biosimilar to Roche’s HERCEPTIN (trastuzumab).  According to the press release, HLX02 is in development for the treatment of human epidermal growth factor receptor 2 (“HER2”) positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer.  The new drug application for HLX02 was accepted by the NMPA in April 2019 and was included in the priority review process in July 2019.  HLX02 met primary endpoints in the Phase 3 clinical trial study in October 2019.  Mabxience will be responsible for developing and commercializing HLX02 products in Argentina, Uruguay, and Paraguay.  Mabxience has previously launched two biosimiliar products in Argentina – rituximab in December 2014, with expanded global access in 2017,  and bevacizumab in November 2016.

Samsung Bioepis receives FDA approval for new dose of ONTRUZANT

On March, 24, 2020, Samsung Bioepis Co., Ltd. announced that the FDA approved a new multi-dose presentation of ONTRUZANT, a biosimilar to Roche’s HERCEPTIN (trastuzumab).  ONTRUZANT was first approved as a 150 mg single-dose vial in January 2019 across all eligible indications, including HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.  The new 420 mg multi-dose vial will be marketed and distributed in the US by Merck until the first half of 2021, at which point ONTRUZANT will become a product of Merck’s new spin-off company.

Xbrane’s XLUCANE on track for regulatory approval

On April 2, 2020, Xbrane Biopharma AB (“Xbrane”) announced that XLUCANE, a biosimilar to Genentech’s LUCENTIS (ranibizumab), is on track towards regulatory approval ahead of LUCENTIS EU patent expiration in July 2022.  Xplore, the ongoing Phase 3 study, remains open for recruitment of new patients and treatment of currently enrolled patients amid the COVID-19 pandemic, Xbrane stating that it will ensure the safety of study participants as well as the integrity of study data by following EMA and FDA recommendations.