• Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
• Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference product to biologics' possessing similar therapeutic properties
• During the month of Jan, Kamada commercialized three biosimilar products in Israel while EMA recommended the approval of two bevacizumab biosimilars. Our team at PharmaShots has summarized 07 key events of the biosimilar space of Jan 2021

Innovent Reported sNDA Acceptance of Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) as 1L Therapy for Hepatocellular Carcinoma

Published: Jan 13, 2021

Product: Alymsys and Oyavas

• The acceptance of sNDA is based on P-III ORIENT-32 study assessing in sintilimab + bevacizumab vs sorafenib in 571 subjects in a ratio (2:1) as a 1L treatment for patients with advanced HCC
• The study met the pre-defined efficacy criteria which showed significant improvement in OS and PFS as assessed by IRRC
• This marks the fifth NDA application of Tyvyt that has been accepted for review by NMPA. Meanwhile, the application also seeks the fourth indication for Byvasda

Kamada Commercialized Three Biosimilar Products in Israel

Published: Jan 14, 2021

Product: Biosimilar

• Kamada signs an agreement with two undisclosed international pharmacies to commercialize three biosimilar product candidates in Israel. The two pharmaceutical companies will be responsible for the development, manufacturing, and supply of three products
• Following the approval from EMA and IMOH, the three products are expected to be launched in Israel b/w 2022 and 2024
• The collaboration will expand Kamada's biosimilar portfolio in Israel which already includes six products previously licensed from Alvotech

Henlius HLX15 (biosimilar, daratumumab) Received IND Approval for Multiple Myeloma in China

Published: Jan 15, 2021

Product: HLX15 (biosimilar, daratumumab)

• Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma
• The company has compared HLX15 in a head-to-head study with reference daratumumab via analytical & preclinical studies. The results demonstrated that HLX15 is highly similar to reference daratumumab
• The company has developed the HLX15 in accordance with the Technical Guidelines of Development and Evaluation of Biosimilar Drugs & EMA Guideline on Similar Biological Medicinal Products

Innovent Out Licensed Byvasda's (biosimilar, bevacizumab) Development and Commercialization Rights to PT Etana in Indonesia

Published: Jan 19, 2021

Product: Byvasda (biosimilar, bevacizumab)

• Innovent to receive milestones for development and commercialization along with royalties on net sales of the therapy in the licensed territory. Etana is committed to launching Byvasda in Indonesia
• The collaboration will enable Byvsada to penetrate into a Southeast Asian market and allow Innovent to bolster its presence globally
• In Jan'2020, Innovent signed an out-license agreement with Coherus to commercialize the biosimilar in the US & Canada

EMA's CHMP Recommended the Approval of Two Bevacizumab Biosimilars

Published: Jan 28, 2021

Product: Alymsys and Oyavas

• The EMA's CHMP has adopted the positive opinion recommending the approval of two biosimilar bevacizumab medicines, Alymsys and Oyavas for the treatment of carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
• Mabxience's Alymsys and STADA's Oyavas both show comparable quality, safety & efficacy to Avastin (bevacizumab)
• Oyavas and Alymsys will be available as 25 mg/ml concentrate for solution for infusion

Bio-Thera Solutions Reported the US FDA's Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

Published: Jan 29, 2021

Product: BAT1706 (Proposed Biosimilar to Avastin)

• The BLA submission is based on data from a P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021
• The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent glioblastoma, mRCC in combination with interferon alfa and persistent, recurrent or metastatic cervical cancer
• The FDA's acceptance brings Bio-Thera closer to providing cancer patients in the US with a high-quality, low-cost treatment option

Henlius Initiated P-III Study of HLX04-O (biosimilar, bevacizumab) in Australia

Published: Jan 29, 2021

Product: HLX04-O (biosimilar, bevacizumab)

• Henlius reported that TGA has approved the filing of a clinical trial for HLX04-O to treat wet-AMD
• The two-part P-III global study is expected to be initiated in Australia to further evaluate the efficacy & safety of HLX04-O (vitreous injection) in the treatment of wAMD
• HLX04-O is a recombinant anti-VEGF humanized mAb ophthalmic injection and has the potential to be one of the first bevacizumab approved for ophthalmic diseases

Image Source: Medium

Related Post: Insights+ Key Biosimilars Events of December 2020