• 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
• During the month of December, Samsung Bioepis presented five-year follow-up results of SB3 (biosimilar, trastuzumab) in a P-III study for breast cancer at SABCS 2021, Theramex entered into an agreement with Enzene Biosciences to develop and commercialize tocilizumab biosimilar for rheumatoid arthritis.  Our team at PharmaShots has summarized 16 key events of the biosimilar space of December 2021

Tot Biopharm’s Pusintin (biosimilar, bevacizumab) Receives NMPA’s Marketing Approval for Non-Squamous NSCLC and Metastatic Colorectal Cancer

Published: Dec 01, 2021

Product: Pusintin (biosimilar, bevacizumab)

• The NMPA has approved Pusintin for marketing in mainland China (Ex-Hong Kong, Macau, and Taiwan regions) for the treatment of patients with advanced, metastatic, or recurrent nsq.NSCLC  and mCRC
• In non-clinical/ clinical studies, Pusintin showed similar PK characteristics as originator drug and clinically equivalent with high similarity in safety and immunogenicity
• Pusintin marks the 1st marketing-approved biosimilar of Avastin in China. The company has commercial-scale manufacturing operations in Suzhou Industrial Park. For Pusintin, company acquires the Perfusion-batch mixed culture technology (PB-Hybrid Technology) for commercial production

Shanghai Henlius Biotech’s Hanbeita (biosimilar, bevacizumab) Receives NMPA’s Approval for mCRC and Non-Squamous NSCLC

 Published: Dec 03, 2021

Product: Hanbeita (biosimilar, bevacizumab)

• The NMPA has approved Hanbeita for mCRC and unresectable, LA, recurrent or metastatic nsq.NSCLC. The approval helps to improve the accessibility of bevacizumab & offers a high-quality option for patients
• The results showed that Hanbeitai is highly similar to Zercepac & no difference in efficacy & safety was observed. The company also develops serplulimab for NSCLC and has a clinical trials program to test the product in combination with bevacizumab
• Hanbeitai marks 4th Henlius' biosimilar to be approved in China, following Hanlikang (rituximab), Hanquyou (trastuzumab) & Handayuan (adalimumab), while Hanquyou is approved in the EU & marketed under brand name Zercepac

Lupin Entered into a Distribution and Marketing Agreement with Biomm for Pegfilgrastim Biosimilar in Brazil

Published: Dec 03, 2021

Product: Pegfilgrastim Biosimilar

• Under the terms of the agreement, Biomm will be responsible to distribute and market biosimilar Pegfilgrastim in Brazil
• The US FDA has accepted the BLA for a proposed biosimilar to reference Neulasta (pegfilgrastim) through a filing using the 351(k) pathway
• Pegfilgrastim is designed to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with CT. The company has developed and commercialized branded and generic formulations, biotechnology products, and APIs in ~ 100 markets in the US, India, South Africa, APAC, LATAM, EU, and the Middle East regions

Prestige Collaborates with Dr. Reddy to Commercialize HD201, a Proposed Biosimilar to Herceptin for HER2 Positive Breast and Metastatic Gastric Cancer

Published: Dec 08, 2021

Product: HD201

• Dr. Reddy gets exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia & will be responsible for local registrations, marketing, and sales in the licensed territories
• Prestige BioPharma will be responsible for the commercial supply of HD201 from its manufacturing facilities in Osong, South Korea
• Prestige BioPharma’s HD201 (trastuzumab) is a proposed biosimilar to Roche’s Herceptin and can be used for the treatment of HER2 positive breast and metastatic gastric cancer

Samsung Bioepis Presents Five-Year Follow-Up Results of SB3 (biosimilar, trastuzumab) in P-III Study for Breast Cancer at SABCS 2021

Published: Dec 08, 2021

Product: SB3 (biosimilar, trastuzumab)

• The company reported the 5yr. follow up results of P-III study evaluating SB3 (trastuzumab biosimilar) vs trastuzumab in 875 patients with HER2-positive early or LA breast cancer for 4yrs. post randomization
• The results showed comparable long-term survival results b/w SB3 and trastuzumab after a median follow-up of 68mos. In 5yrs. survival analysis, EFS rate (79.8% & 75.0%), 5yrs. OS was also comparable with OS rate (92.5% & 85.4%)
• In the post-hoc analysis, SB3 was compared with non-drifted trastuzumab which showed an EFS rate (79.8% vs 82.5%), OS rate (92.5% & 91.4%). SB3 was approved in the US under the brand name Ontruzant & is marketed by Organon

Richter Signs a License Agreement with Hikma to Commercialize Denosumab, a Proposed Biosimilar of Prolia and Xgeva in the US

Published: Dec 09, 2021

Product: Denosumab

• Richter is eligible to receive up front along with milestones for development stages & is responsible for the development of the products & conduct both P-I & III studies along with supply finished commercial products in the US
• Hikma to get exclusive rights to commercialize in the US & is responsible for registering the products with the US FDA
• Denosumab is a human mAb & is used for the treatment of osteoporosis and fractures due to bone metastasis which is currently in P-I & III clinical studies. The product is marketed under two brands i.e., Prolia (60mg/ml solution for inj. in PFS) & Xgeva (120mg/1,7 ml solution for inj. in a vial)

Samsung Bioepis’s SB12, a Proposed Biosimilar to Soliris (eculizumab) Meet its 1EPs in P-I Study for Paroxysmal Nocturnal Haemoglobinuria

Published: Dec 11, 2021

Product: SB12

• The company reported the results from the P-I study to evaluate SB12 (300mg) vs eculizumab via IV infusion in a ratio (1:1:1) in 240 patients with PNH
• The study met all 1EPs that showed PK equivalence and comparable PD profiles b/w SB12 and eculizumab. The 2EPs included AUClast and Cmax while safety profiles including immunogenicity were also comparable b/w SB12, EU-sourced eculizumab, and US-sourced eculizumab treatment groups & no death or discontinuation due to TEAEs were observed
• Soliris is a humanized mAb that binds to the human C5 complement protein & is currently used for the treatment of PNH, aHUS, gMG, and NMOSD

Xbrane Biopharma Seeks to Initiate the Development of Keytruda and Darzalex Biosimilar

Published: Dec 13, 2021

Product: Keytruda and Darzalex Biosimilar

• Xbrane initiates the development of 2 biosimilar products referencing Keytruda & Darzalex along with Xdivane (biosimilar referencing Opdivo)
• Keytruda is a PD1 inhibitor used for oncology & Darzalex is a CD38 inhibitor used for MM & light chain amyloidosis. These biosimilar candidates along with Xdivane form an oncology biosimilar portfolio addressing $199.7M of combined annual reference product sales which are expected to launch in 2028-2029 on expiry of respective patents
• The company plans to develop 1 new biosimilar candidate/yr. Xbrane expanded its high-yield protein expression platform into mammalian cells with the development of Xdivane, which lead to 5 recently approved patents

MS Pharma Signs an Exclusive License Agreement with Bioeq to Commercialize FYB201 (biosimilar, ranibizumab) in MENA Region

Published: Dec 14, 2021

Product: FYB201 (biosimilar, ranibizumab)

• Under an exclusive agreement, MS Pharma will initiate the registration procedures in MENA shortly & will be responsible for the registration and commercialization of FYB201 in the licensed countries
• Bioeq & Formycon collaborated to develop FYB201 where Bioeq will be responsible for the development and supply of biosimilar & is currently under registration in the EU & the US. Additionally, Formycon will participate in the commercialization revenues of FYB201 in all territories, following approval of FYB201
• Ranibizumab, a biosimilar to Novartis’ Lucentis is indicated for the treatment of AMD and other serious eye conditions

Celltrion Reports Results of Herzuma (biosimilar, rastuzumab) + Gedatolisib in P-II Study for the Treatment of Metastatic Breast Cancer

Published: Dec 14, 2021

Product: Herzuma (biosimilar, rastuzumab) + Gedatolisib

• The P-II study evaluates Herzuma (a trastuzumab biosimilar) + gedatolisib in patients with HER2–positive mBC with a PIK3CA aberration whose cancers had progressed after multiple lines of therapy
• The results showed a 58.8% ORR with manageable toxicity, DCR was 82.4%, m-PFS was 5.9mos. Additionally, 3 patients had progressive disease, 4 with SD, and 10 showed PR. The results were presented at SABCS 2021
• Trastuzumab is a mAb that targets HER2 & binds to the HER2/neu receptor and reduces HER2 expression along with the growth of blood vessels to support tumor growth while Gedatolisib targets the mTOR/PIK3 signaling pathway

Alvotech’s AVT02 (biosimilar, adalimumab) Receives EC’s Approval for the Treatment of Autoimmune Disease

Published: Dec 15, 2021

Product: AVT02 (biosimilar, adalimumab)

• The EC has granted marketing authorization for Alvotech’s adalimumab biosimilar AVT02 to reference Humira. In Sept., the product received a recommendation for approval from the EMA’s CHMP includes all EU Member States along with countries in the EEA, Iceland, Liechtenstein, and Norway
• AVT02 is a high concentration biosimilar to Humira (adalimumab) which is used for autoimmune and inflammatory conditions
• On Dec. 7, 2021, Alvotech entered into a definitive business combination agreement with Oaktree & combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO”, following the completion of the transaction

Merck & Nanostring Reports Results of Trazimera (biosimilar, trastuzumab) in P-II (KEYRICHED-1) Trial for the Treatment of Breast Cancer

Published: Dec 20, 2021

Product: Trazimera (biosimilar, trastuzumab)

•  The P-II (KEYRICHED-1) trial evaluates the pCR rate of pembrolizumab in combination with trastuzumab biosimilar and pertuzumab in patients with early breast cancer with molecular HER2-enriched intrinsic subtype
• The results showed a 52% confirmed pCR rate in 46 evaluable patients, 52 (55%) had the HER2-E subtype by PAM50, 48 were included in the treatment phase, 65% had tumors & 30% were positive for lymph node involvement
• Additionally, the therapy also showed a confirmed pCR rate for HER2-positive/ HR-positive tumors & HER2-positive/HR-negative tumors (38.5% vs 58.5%) & no new safety signals were observed

Sandoz Submits BLA to US FDA for EG12014, a Proposed Biosimilar Trastuzumab to Treat HER2-positive Breast Cancer and Metastatic Gastric Cancers

Published: Dec 20, 2021

Product: EG12014

• The submission is based on analytical, pre-clinical, and clinical data to evaluate proposed biosimilar trastuzumab (150mg, IV) in breast & gastric cancer patients. Trastuzumab biosimilar is being developed by EirGenix
• Sandoz continues to build on generic and biosimilar oncology portfolios to increase patient access and contribute to the sustainability of healthcare systems. Trastuzumab is a mAb that was used to treat HER2-positive breast cancer and metastatic gastric cancers
• In Apr 2019, Sandoz entered into a license agreement with EirGenix where Sandoz get the right to commercialize EG12014 (biosimilar, trastuzumab) globally (Ex- China and Taiwan). EirGenix is responsible for the development and manufacturing of the product

Theramex Entered into an Agreement with Enzene Biosciences to Develop and Commercialize Tocilizumab Biosimilar for Rheumatoid Arthritis

Published: Dec 23, 2021

Product: Tocilizumab Biosimilar

• The companies collaborated to develop, and commercialize a biosimilar of Roche’s RoActemra (Tocilizumab)
• Tocilizumab + MTX is indicated for the treatment of RA & plans to commercialize the product from 2026 in the EU, UK, Switzerland, and Australia
• Theramex’s Tocilizumab product will be available in parenteral vials, SC PFS & autoinjectors. RoActemra is indicated for the treatment of RA, systemic JIA in patients aged ≥1yr., juvenile idiopathic polyarthritis in patients aged 2 yr. & giant cell arteritis

Innovent Reports the NMPA Acceptance of sNDA for Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) for EGFR-Mutated Non-squamous NSCLC

Published: Dec 27, 2021

Product: Byvasda (biosimilar, bevacizumab)

• The sNDA is based on the P-III (ORIENT-31) trial to evaluate sintilimab with/out bevacizumab biosimilar & CT vs PBO + CT in a ratio (1:1:1) in patients with EGFR-mutated nsq.NSCLC who had disease progression after EGFR-TKI therapy
• The results showed an improvement of IRRC-assessed PFS over sintilimab + CT & PBO + CT, improvement in ORR & DoR while safety profile was consistent with previously reported studies of sintilimab & bevacizumab biosimilar & no new or unexpected safety signals were observed & was well-tolerated
• The company is currently conducting 20+ clinical studies of sintilimab globally for cancer including 10+ registrational or pivotal clinical trials

Coherus’s Receives the US FDA’s Approval of CHS-1420 (biosimilar, adalimumab) for the Treatment of Chronic Plaque Psoriasis

Published: Dec 30, 2021

Product: CHS-1420 (biosimilar, adalimumab)

• The approval is based on a (CHS-1420-02) study to evaluate the efficacy, safety & immunogenicity of Yusimry vs Humira in 545 subjects with moderate to severe chronic PsO
• The results showed that Yusimry was equivalent to adalimumab based on the 1EPs, 75% improvement in PASI-75 @12wks. Additionally, the CHS-1420-03 trial assessed the PK bioequivalence of Yusimry vs Humira after SC administration of a single (40mg) dose & demonstrated similarity on all PK endpoints
• Yusimry is Coherus' second FDA-approved product & is expected to launch in the US on July 2023, under the collaboration with AbbVie

Source: Center for Biosimilar

Related Post: Insights+ Key Biosimilars Events of November 2021