Insights+ Key Biosimilars Events of January 2023

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Insights+ Key Biosimilars Events of January 2023


  • 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 January, Celltrion reported P-III trial results of CT-P16 (biosimilar, bevacizumab) for non-squamous non–small cell lung cancer, STADA and Xbrane received the MHRA’s approval for Ximluci (biosimilar, ranibizumab) to treat retinal diseases. Our team at PharmaShots has summarized 16 key events of the biosimilar space of January 2023

Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive Health Canada’s Approval

Date- January 03, 2023  

Product: Hadlima (biosimilar, adalimumab)

  • Health Canada has approved Hadlima, a high-concentration, citrate-free adalimumab biosimilar referencing Humira for RA, polyarticular JIA, AS, PsA, Crohn’s disease, UC, hidradenitis suppurativa, PsO, uveitis. Hadlima HC was developed through a commercialization agreement b/w Samsung Bioepis & Organon
  • The approval was based on the P-I trial evaluating PK, safety & tolerability of the new SB5 formulation (40mg/0.4mL) vs prior SB5 formulation (40mg/0.8mL) in healthy male patients
  • The study showed PK equivalence b/w new SB5 & prior SB5 formulation & both formulations were well tolerated with similar safety profiles. Hadlima will also be commercialized by Organon in 2023

Alteogen Signed an Exclusive License Agreement with Sandoz to Develop and Commercialize Biosimilar Products

Date- January 03, 2023  

Product: N/A

  • Alteogen will receive an up front & additional fees upon achievement of development, regulatory & sales milestones along with royalties on sales of the commercialized product
  • Sandoz to get the global rights to use Alteogen’s ALT-B4, a novel hyaluronidase derived developed using Hybrozyme technology to develop & commercialize the SC version of a Sandoz biosimilar product & also obtain an option to license the Hybrozyme technology for 2 products
  • Alteogen will be responsible for the regulatory, development & commercial supply of ALT-B4 to Sandoz.  At the time of each option's exercise, both companies will negotiate separate agreements for 2 option products & responsible for an additional products that Sandoz may decide to develop

STADA and Xbrane Receives the MHRA’s Approval for Ximluci (biosimilar, ranibizumab) to Treat Retinal Diseases

Date- January 06, 2023  

Product: Ximluci (biosimilar, ranibizumab)

  • The MHRA has granted marketing authorization for Ximluci, a biosimilar referencing Lucentis in Great Britain. Ximluci is expected to be available in the UK in 2023
  • The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC
  • Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults. STADA and Xbrane collaborated in July 2018 for the development and manufacturing of the finished product where STADA holds the marketing authorizations and the commercial rights to the biosimilar across all EU, the US, multiple countries in the MENA region, and selected APAC markets

Alvotech and Teva Reports the US FDA’s Acceptance of BLA for Review of AVT04, a Proposed Biosimilar to Stelara (ustekinumab)

Date- January 06, 2023  

Product: AVT04

  • A BLA for AVT04, a proposed biosimilar to Stelara (ustekinumab) has been accepted for review by the US FDA for the treatment of a variety of inflammatory conditions. The US FDA’s review is expected to be completed in H2’23
  • Under the Aug 2020 agreement, Alvotech and Teva collaborated for the exclusive commercialization in the US of five biosimilar product candidates incl. an adalimumab biosimilar (AVT02) referencing Humira
  • AVT02 is currently under the US FDA’s review and is expected to enter the US market in July 2023, along with 6 other adalimumab biosimilars. In May 2022, Alvotech highlighted the positive results from a PK similarity study for AVT04

Coherus Acquires Rights from Klinge Biopharma for Eylea Biosimilar Candidate

Date- January 09, 2023  

Product: FYB203

  • Klinge will receive an up front of ~$32.5M and Coherus common stock & is also eligible to receive other regulatory and launch milestones and share profits. The transaction is expected to be completed in Q1’23
  • Coherus to get an exclusive US commercialization right from Klinge Biopharma for FYB203, a biosimilar candidate to aflibercept & plans to file a BLA for FYB203 in 2023 with an expected launch in 2025 if the application is approved
  • FYB203 is currently being evaluated in a P-III trial (MAGELLAN-AMD) & results are expected in the next few weeks. The therapy is also being studied in the (MAGELLAN-AMD) trial for the treatment of nAMD

Celltrion Collaborated with Rani Therapeutics for the Development of RT-111 (biosimilar, ustekinumab)

Date- January 09, 2023  

Product: RT-111 (biosimilar, ustekinumab)

  • The companies collaborated for the development of RT-111, an orally administered ustekinumab biosimilar
  • Under the terms of the license and supply agreement, Celltrion is exclusively supplying Rani with ustekinumab biosimilar drug substance (CT-P43) required for RT-111. Additionally, Rani will get an exclusive license to use CT-P43 for the development and commercialization of RT-111
  • Following a P-I clinical trial, Celltrion gets the right of first negotiation to acquire global rights to RT-111. The RaniPill capsule, a form of oral dosing for biologics and drugs was developed by Rani as an alternative to SC or IV inj.

Alvotech Reports Initiation of Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi and Simponi Aria

Date- January 11, 2023  

Product: AVT05

  • The company initiates the PK study evaluating the PK, safety, and tolerability of AVT05 vs Simponi in healthy adult patients
  • A biosimilar to Humira, Alvotech's first commercially available product has been approved in 35 countries globally and has been launched in the EU & Canada. Golimumab is a mAb that inhibits TNF alpha
  • The eight products and product candidates in Alvotech's current portfolio are intended to treat cancer, osteoporosis, respiratory illnesses, and autoimmune diseases. AVT05, a biosimilar candidate for Simponi and Simponi Aria has not received regulatory approval in any country

Alvotech Expands its Collaboration with Fuji Pharma to Add a New Biosimilar Candidate

Date- January 13, 2023  

Product: N/A

  • The collaboration expanded to add a new biosimilar candidate & increase patient access to vital biologic medicines in Japan. In Oct 2022, the companies have submitted an application to MHLW for marketing approval of the first biosimilar candidate
  • The agreement which covers 7 biosimilars, incl. the new candidate, to be developed & manufactured by Alvotech & commercialized by Fuji in Japan, was first announced by Alvotech & Fuji in Nov 2018. It was previously extended in Dec 2020 & Feb 2022
  • Fuji Pharma’s main focus is on the development & commercialization of hormone medicines for obstetrics & gynecology therapies, injectable drugs incl. diagnostic pharmaceutical products

Bio-Thera Solutions Receives the NMPA’s Approval of BAT1806, a Biosimilar to Actemra

Date- January 16, 2023  

Product: BAT1806

  • The NMPA has approved BAT1806, a biosimilar of Actemra (tocilizumab) in China for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome
  • BAT1806 is highly similar to the reference drug in terms of quality, safety, and efficacy acc. to extensive analytical similarity, non-clinical similarity & clinical studies
  • The additional biosimilar products are being developed by the company, incl. proposed biosimilars for Simponi, Stelara, and Cosentyx, which are all undergoing in the P-III study, and a proposed biosimilar for Nucala in the P-I study. The US FDA & EMA has accepted the MAA of BAT1806/BIIB800

Dong-A ST Reports P-III Study Results of Ustekinumab Biosimilar DMB-3115 for the Treatment of Chronic Plaque Psoriasis

Date- January 17, 2023  

Product: DMB-3115

  • The P-III therapeutic equivalence study evaluating the safety, efficacy, and immunogenicity of DMB-3115 vs Stelara in 605 patients with mod. to sev. chronic plaque psoriasis in the US & 9 other countries incl. Poland, Estonia, and Latvia. DMB-3115 has been jointly developed by Dong-A Socio Holding & Meiji Seika Pharma
  • The results showed that ustekinumab biosimilar (DMB-3115) has similar safety and efficacy profiles to the reference Stelara, no clinically significant difference in safety were observed
  • Dong-A ST received the commercialization and development rights to the biosimilar in July 2020. The company is expected to submit the MAA to the US FDA & EMA in H1’23

Celltrion Healthcare’s Vegzelma (biosimilar, bevacizumab) Receives the Health Canada’s Approval for the Treatment of Cancer

Date- January 19, 2023  

Product: Vegzelma (biosimilar, bevacizumab)

  • Health Canada granted a NOC for Vegzelma, a biosimilar to Avastin for multiple forms of cancer i.e., mCRC, NSCLC, epithelial ovarian, FTC, PPC & glioblastoma
  • Health Canada authorization was based on a comprehensive data package of analytical, preclinical & clinical studies which revealed that in terms of effectiveness, safety & PK, Vegzelma was highly similar to Avastin
  • The company offers a patient support program i.e., CELLTRION CONNECT to provide access to patients & healthcare for Vegzelma treatment & also offers guidance with reimbursement navigation, financial assistance, inj. and nurse support services & pharmacy support services to eligible patients. Vegzelma was approved in the EU in Aug 2022 while UK & Japan in Sept 2022

Dr. Reddy’s Reports the Completion of Clinical Studies of Rituximab Biosimilar

Date- January 20, 2023  

Product: Rituximab Biosimilar

  • Dr. Reddy will get ready to file in the US, EU, and other regions after the proposed rituximab biosimilar candidate DRL RI's full set of clinical studies is successfully completed
  • DRL_RI references Rituxan, a cluster of differentiation 20 directed cytolytic antibody used in the treatment of adult patients with RA, non-Hodgkin's lymphoma, CLL, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis
  • The biosimilar is already approved in India and over 25 other emerging markets. Dr. Reddy's is currently working with Fresenius Kabi to commercialize its proposed biosimilar of rituximab in the US & also plans to commercialize the product in the EU and other geographies

Celltrion Reports P-III Trial Results of CT-P16 (biosimilar, bevacizumab) for Non-Squamous Non–Small Cell Lung Cancer

Date- January 21, 2023  

Product: CT-P16 (biosimilar, bevacizumab)

  • The P-III trial evaluating CT-P16 vs EU-Approved Avastin (15mg/kg, q3w; ≤ 6 cycles) with paclitaxel (200mg/m2) & carboplatin in 689 patients with metastatic or recurrent non-sq. NSCLC across 164 study sites in 21 countries    
  • CT-P16 showed an equivalent efficacy & similar PK, safety, and immunogenicity to reference EU-bevacizumab. In the primary efficacy EPs, ORR (42.40% vs 42.07%); CR (0.6% vs 0.9%); PR (41.8% vs 41.2%) while the 2EPs incl. response duration (7.2 vs 6.3mos.), m-TTP, PFS, and OS were also similar
  • Patients experienced ≥1 TEAEs (96.2% vs 93%); TEAEs considered to be related to the use of bevacizumab (51.6% vs 50.6%); patients were positive for antidrug Abs (22.6% vs 24.1%) regarding immunogenicity

Alvotech and Bioventure Receive the SFDA’s Approval of AVT02 (biosimilar, adalimumab) in Saudi Arabia

Date- January 24, 2023  

Product: AVT02 (biosimilar, adalimumab)

  • SFDA has approved AVT02, an adalimumab biosimilar referencing Humira for manufacturing & distribution in Saudi Arabia for RA & other inflammatory diseases
  • In Saudi Arabia, the biosimilar will be marketed under the name Simlandi. AVT02 is currently under the US FDA’s review with a manufacturing facility inspection scheduled for March 2023 & decision date of Apr 2023
  • Under the license agreement for AVT02, Alvotech will lead the development & manufacturing while Bioventure will be responsible for the commercialization of the biosimilar. AVT02 is a mAb & approved biosimilar to Humira & has been approved in the 27 countries of the EU, Norway, Iceland, Liechtenstein, the UK & Switzerland as Hukyndra; in Australia as Ciptunec/Ardalicip & in Canada as Simlandi

HK inno.N Entered into an Exclusive License Agreement with mAbxience for Denosumab Biosimilar to Treat Bone Disease

Date- January 25, 2023  

Product: Denosumab Biosimilar

  • HK inno.N collaborated with mAbxience for a denosumab biosimilar referencing Prolia/Xgeva in the Korean market. The biosimilar will be used to treat and prevent osteoporosis and cancer-related skeletal complications
  • Under the terms of the agreement, HK inno.N will obtain the marketing rights for a 60 & 120mg version of the denosumab biosimilars & will apply for domestic approval and proceed with sales. The patent for both drugs is expected to expire in 2025
  • Additionally, clinical trials are being conducted by mAbxience to confirm the biosimilars' clinical equivalence to the original denosumab products

Chong Kun Dang Pharmaceutical Reports P-III Trials of CKD-701 (biosimilar, ranibizumab) for the Treatment of Neovascular Age-Related Macular Degeneration

Date- January 28, 2023  

Product: CKD-701 (biosimilar, ranibizumab)

  • The P-III trial evaluates CKD-701 vs ranibizumab in a ratio (1:1) in 312 patients with nAMD in 25 hospitals across Korea
  • The results showed that CKD-701 has comparable clinical efficacy & safety with the reference Lucentis, 98.95% vs 98.62% patients had lost fewer than 15 letters of BCVA @3mos., no significant difference b/w groups in BCVA @6 & 12mos. The trial was published in PloS One
  • The 2EPs of safety and immunogenicity were also comparable b/w groups improvement of 15 letters in BCVA @ 3/6/12mos. were 16%/22%/25% vs 17%/20%/21% decreased CRT at all time points with no significant differences’ b/w groups, AEs (51% vs 50%), SAEs (10% vs 10%), low cumulative incidence of ADAs was similar b/w groups @~12mos.

Related Post: Insights+ Key Biosimilars Events of December 2022

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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