• 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 December, Celltrion receives CHMP's positive opinion for CT-P17 (biosimilar, adalimumab) while Samsung Bioepis initiated P-II study SB16. Our team at PharmaShots has summarized 10 key events of the biosimilar space of Dec 2020

Henlius Receives the NMPA's Approval for HLX03 (biosimilar, adalimumab) to Treat Autoimmune Disease

Published: Dec 07, 2020

Product: HLX03 (biosimilar, adalimumab)

• NMPA has approved HLX03 for the treatment of RA, AS, and PsO. It is the first China-developed biosimilar, approved both in China and in the EU
• The approval marks the expansion of the Henlius  commercial pipeline into the field of autoimmune diseases and the scope of patients befitted with the therapy
• Henlius will continue optimizing and upgrading the product, and cooperating with Wanbang Biopharma to promote the commercialization of biosimilar, to bring high-quality treatment options to patients suffering from autoimmune diseases

Celltrion Receives the CHMP 's Positive Opinion for CT-P17 (biosimilar, adalimumab)

Published: Dec 11, 2020

Product: CT-P17 (biosimilar, adalimumab)

• The EMA's CHMP has adopted a positive opinion for approval of CT-P17, biosimilar referencing Humira, recommending its approval for all available indications
• Celltrion filed MAA of CT-P17 with the EMA in Mar'2020. The EC will review the CHMP's positive opinion which would give a final marketing approval in 1-3mos.
• If approved, Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

Published: Dec 14, 2020

Product: Biosimilar

• The agreement strengthens the ongoing collaboration b/w the companies signed in 2018 to commercialize Alvotech's biosimilar portfolio in Japan
• Fuji Pharma currently owns a minority stake in Alvotech and now can enter new therapeutic areas following the agreement
• With the extension of the agreement, Fuji Pharma has a leading biosimilar pipeline in Japan. Fuji Pharma will use its strong local expertise in commercializing Alvotech's portfolio in Japan

Samsung Bioepis Initiated P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Dec 15, 2020

Product: Prolia (denosumab)

• The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis
• The company has initiated the P-I study to compare the PK/PD, safety, tolerability, and immunogenicity b/w SB16 and Prolia in healthy volunteers in Oct'2020
• Samsung Bioepis has three biosimilar candidates  SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III development

Bio-Thera Collaborates with Biomm to Commercialize BAT1706 (biosimilar, bevacizumab) in Brazil

Shots:

Published: Dec 17, 2020

Product: Byvasda (biosimilar, bevacizumab)

• Biomm to get exclusive rights to distribute & market the therapy in Brazil. Bio-Thera will be responsible for the development & commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China
• Bio-Thera's BAT1706 has completed a global P-III comparative clinical study assessing the efficacy, safety, PK, and immunogenicity of BAT1706 vs EU-bevacizumab + CT in patients with advanced nsq. NSCLC
• Biomm will be responsible for filing the dossier in Brazil. The partnership will leverage Biomm's presence, sales, and marketing capabilities in Brazil

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Published: Dec 18, 2020

Product: Hyrimoz (biosimilar, adalimumab)

• Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology
• A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education for patients
• Hyrimoz is a fully human TNF blocker. The notice of compliance has been issued for 3 SC dosage forms: 40 mg/0.8 mL & 20 mg/0.4mL in prefilled syringe, 40 mg/0.8 mL in autoinjector

Amgen's Riabni (biosimilar, rituximab) Received the US FDA's Approval for Multiple Diseases

Published: Dec 18, 2020

Product: Riabni (biosimilar, rituximab)

• The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden
• The WAC of Riabni will be 23.7% lower than the Rituxan in the US and will be available at a WAC of $716.80/ 100mg and $3,584.00/ 500mg single-dose vial
• Riabni is a biosimilar to Rituxan, approved for the treatment of NHL, CLL, GPA, MPA and ill be made available in the US in Jan 2021

Innovent's Sulinno (biosimilar, adalimumab) Received China's NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

Published: Dec 18, 2020

Product: Sulinno (biosimilar, adalimumab)

• The approval is granted in pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults, who do not respond adequately to corticosteroids.
• These are fifth and sixth approved indications of Sulinno in China and it was first approved by NMPA on Sep 2, 2020
• Sulinno is an adalimumab biosimilar which is a recombinant human anti-TNF-a mAB developed by Innovent and are indicated in rheumatoid arthritis, ankylosing spondylitis, psoriasis, and polyarticular juvenile idiopathic arthritis

AMCP Partnership Forum Develops Strategies to Support the Use and Development of Biosimilar in the US

Published: Dec 21, 2020

Product: Biosimilar

• Forum participants analyzed key barriers and misinformation around biosimilar adoption to bridge gaps in provider knowledge, generate RWE evidence, streamline biosimilar approval processes, and improve education across safety and efficacy for biological drugs
• Participants suggested multiple strategies around education, language, RWE, benefit design, legislation, regulations, confidence, and thought sharing to navigate the complexities of the biosimilar terrain
• All findings & recommendations from the AMCP Partnership Forum will be published in an upcoming issue of AMCP's Journal of Managed Care + Specialty Pharmacy

Innovent's Byvasda (biosimilar, bevacizumab) Receives NMPA's Approval for the Treatment of Adult Recurrent Glioblastoma

Published: Dec 21, 2020

Product: Byvasda (biosimilar, bevacizumab)

• The indication is the third indication approved for the therapy, previously it was approved for advanced NSCLC and metastatic colorectal cancer
• The launch of Byvasda has provided Chinese patients with high quality and relatively more affordable bevacizumab biosimilar injection
• Byvasda is an anti -VEGF humanized mAb. In Jan'2020, Innovent out-licensed the commercial rights of the biosimilar in the US and Canada to Coherus BioSciences

Related Post: Insights+ Key Biosimilars Events of November 2020