Insights+ Key Biosimilars Events of February 2023

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Insights+ Key Biosimilars Events of February 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 February, Alvotech entered into a commercialization agreement with Advanz Pharma for AVT23, a proposed biosimilar to Xolair (omalizumab), Alvotech and STADA report EMA acceptance of MAA for AVT04, a proposed biosimilar to Stelara (ustekinumab). Our team at PharmaShots has summarized 15 key events of the biosimilar space of February 2023

Shanghai Henlius Biotech Reports the First Patient Dosing of HLX15 (biosimilar, daratumumab) in P-I Clinical Trial for Multiple Myeloma

Date- February 01, 2023 

Product: HLX15 (biosimilar, daratumumab)

  • The first patient has been dosed in the P-I trial that consists of 2 parts (parts 1 & 2) evaluating HLX15 (anti-CD38 IgG1κ mAb) vs daratumumab in 234 patients with MM
  • Part 1 is an open-label, two-arm P-Ia study & part 2 is a three-arm P-Ib study evaluating HLX15 (8mg/kg) vs China & US-sourced daratumumab in a ratio (1:1) & (1:1:1) in 24 & 204 patients while part 2 is a three-arm P-Ib study. The early phase of part 1 includes a safety run-in period with 3-6 patients to receive HLX15 (IV), monitored for safety for 1wk.
  • The 1EP is the area under the serum drug concentration-time curve from time 0 to infinity & 2EPs incl. other PK parameters, safety & immunogenicity. In preclinical studies, HLX15 is highly similar to daratumumab

Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US

Date- February 01, 2023 

Product: Amjevita

  • The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases. Amjevita will be available in a prefilled syringe & auto-injector pen
  • Amjevita (40mg) is available with 2 pricing options. One pricing will be a 5% discount below the current list price of Humira while the other pricing will be a 55% discount. Multiple other adalimumab biosimilars are set to launch in the US in July 2023
  • In Sept 2016, Amjevita was the first adalimumab biosimilar to be approved in the US & is also available in the EU & Canada. The company provides a patient support program i.e., AMJEVITA SupportPlus incl. financial support information & educational resources

Fresenius Kabi Entered into a License Agreement with Formycon to Commercialize FYB202 (biosimilar, ustekinumab)

Date- February 02, 2023 

Product: FYB202 (biosimilar, ustekinumab)

  • Formycon is eligible to receive up front & milestones upon the achievement of regulatory events with post-commercialization value to be shared equally by both companies. The proposed biosimilar is currently in the advanced clinical stage
  • Fresenius Kabi will get exclusive commercialization right to FYB202, a proposed biosimilar referencing Stelara in key global markets after successful approval by respective health agencies, incl. Germany as well as parts of the MENA region and Latin America
  • Formycon will be in charge of development and registration with health authorities. Fresenius Kabi will expand its product portfolio with other autoimmune disease treatment options

Alvotech Entered into Commercialization Agreement with Advanz Pharma for AVT23, a Proposed Biosimilar to Xolair (omalizumab)

Date- February 06, 2023 

Product: AVT23

  • The companies collaborated to commercialize AVT23, a proposed biosimilar to Xolair (omalizumab) in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand
  • Alvotech will be responsible for the development and manufacture while Advanz Pharma will be responsible for the registration and commercialization. The agreement focuses to provide patients access to more affordable biologics globally
  • Alvotech collaborated with BiosanaPharma in Feb 2022 for the co-development of AVT23. Omalizumab, an Ab targeting free IgE & is indicated to treat patients with allergic asthma, chronic spontaneous urticaria, and nasal polyps

Sandoz Reports the US FDA Acceptance of BLA for Proposed Biosimilar Denosumab

Date- February 06, 2023 

Product: Prolia and Xgeva

  • The US FDA has accepted the BLA for a proposed biosimilar denosumab (Prolia and Xgeva) for various conditions incl. osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss
  • The submission was based on the comprehensive analytical and clinical data package, incl. the P-I/III trial (ROSALIA) which showed a similarity b/w Sandoz’s denosumab and the reference medicine in postmenopausal osteoporosis women in terms of safety, immunogenicity, PD, efficacy & PK
  • The company continues to build a biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability

Formycon AG Reports Preliminary P-III Trial (MAGELLAN-AMD) Results FYB203, a Proposed Biosimilar to Eylea

Date- February 06, 2023 

Product: FYB203

  • The company published positive preliminary efficacy and safety data from the P-III trial (MAGELLAN-AMD) evaluating aflibercept biosimilar (FYB203) vs Eylea
  • The study met the primary efficacy EPs & showed biosimilarity b/w 2 products in patients with neovascular wet AMD while no differences in safety or immunogenicity were seen. The 1EPs measure the change in best corrected visual acuity after 8wks. from baseline
  • Formycon is now announcing the success of FYB203 emphasizing its leadership in this field, following the approval & market launch of an ophthalmological biosimilar for Lucentis (FYB201, marketed as Ongavia in the UK, Ranivisio in the EU, and Cimerli in the US

Alvotech and STADA Report EMA Acceptance of MAA for AVT04, a Proposed Biosimilar to Stelara (ustekinumab)

Date- February 09, 2023 

Product: AVT04

  • The EMA has accepted a MAA of AVT04, a proposed biosimilar to Stelara (ustekinumab). The EMA opinion on AVT04 will be expected in H2’23
  • Alvotech’s focus is to provide patients access to more affordable biologics globally while the end-to-end biosimilars platform will support the development and manufacture of multiple products
  • In May 2022, Alvotech highlighted the confirmatory clinical, safety & efficacy study of AVT04 that met its 1EPs & showed therapeutic equivalence b/w Alvotech’s biosimilar candidate and the reference product for the treatment of chronic plaque-type psoriasis. Alvotech also reported the PK similarity study results of AVT04

Samsung Bioepis Reports P-IV Study of SB4 (biosimilar, etanercept)

Date- February 10, 2023 

Product: SB4 (biosimilar, etanercept)

  • The first P-IV postmarketing surveillance study evaluates SB4 (qw, SC) in 316 patients with axSpA, RA, PsA, and PsO in Korea. Both etanercept-naïve patients or patients switched from reference etanercept
  • The results showed comparable effectiveness & safety to historical SB4 real-world evidence without any new significant safety signals, AEs were reported in 17.8% of patients, ADRs (9.9%), serious AEs (1.3%), and most AEs were mild or mod. (66.7% & 31.1%, respectively) & unrelated to SB4 (58.9%)
  • Additionally, mean disease activity scores were significantly lower over baseline in etanercept-naïve patients with AS & RA (2.7 vs 6.2); in switched patients (1.0 vs 1.3) @24wks. The study had a high retention rate similar to a previous study

Shanghai Taiyin Biotechnology Reports Preclinical Study of Omalizumab Biosimilar KA

Date- February 11, 2023 

Product: Omalizumab Biosimilar

  • Preclinical studies of the proposed omalizumab biosimilar KA showed similarities to Xolair in terms of analytical characteristics, in vitro biological activity, pharmacology, and toxicology in animals. Omalizumab is a mAb targeting IgE used to treat mod. to sev. asthma
  • Structure & binding activity were similar to the reference Xolair, no significant differences in pharmacological, PK, and toxicity profiles were observed. The mouse model's findings also revealed that in vivo pharmacologic effects were similar
  • Additionally, KA has similar activity to the omalizumab reference product in cell-free, in vitro, and relevant in vivo preclinical models, and the results demand a clinical analysis of biosimilarity

Biocon Biologics and its Partner Viatris Receive the Complete Response Letter from the US FDA for Bevacizumab Biosimilar

Date- February 12, 2023 

Product: Bevacizumab Biosimilar

  • The US FDA has issued a CRL for biosimilar referencing Avastin (bevacizumab) previously submitted by Viatris & also requested additional data to be submitted
  • The US FDA did not identify any issues with the preclinical and clinical trial results that were submitted in the dossier as part of the BLA for the bevacizumab product. Additionally, Biocon has submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the US FDA
  • Bevacizumab biosimilar is currently available in Canada where it is marketed under the name Abevmy. If it is approved in the US, it will be 5th bevacizumab biosimilar to receive the US FDA approval

Similis Bio Collaboration with Novel351k to Develop Multiple Biosimilar Programs for Cancer and Autoimmune Diseases

Date- February 14, 2023 

Product: N/A

  • The companies collaborated to co-develop 3 biosimilar programs across hard-to-treat diseases. The collaboration combines Similis’ broad CMC expertise with Novel351k’s innovative clinical approach to advance the delivery of life-saving therapies to eligible patients at lower cost
  • Similis will lead the cell line development, analytics, process development & cGMP production, leading to PK/PD trials. Novel351k will use its experience with regulatory and clinical strategies to advance the program's development toward commercialization
  • The therapies developed under the collaboration have a $15B+ annual market value. Under the co-development agreement, Similis Bio & Novel351k is expected to be valued at $100M incl. development milestones and royalties for ~10yrs.

Henlius Reports the US FDA Acceptance of BLA for Proposed Biosimilar Trastuzumab HLX02

Date- February 15, 2023 

Product: HLX02

  • The US FDA has accepted the BLA for the proposed biosimilar trastuzumab HLX02 (submitted by the company's partner Accord BioPharma) indicated for breast cancer & metastatic gastric cancer corresponding to all the approved indications of trastuzumab
  • The submission was based on robust structural & functional analytical data using multiple orthogonal techniques & head-to-head studies incl. comparative analytical studies, nonclinical studies, a P-I PK similarity study & P-III study of HLX02 vs trastuzumab which showed that HLX02 & reference trastuzumab are highly similar in terms of quality, safety & efficacy
  • HLX02 was approved in 30+ countries & Henlius focuses to advance the delivery of high-quality, affordable & innovative therapies to patients globally

Fresenius Kabi Launches Stimufend (biosimilar, pegfilgrastim) for Febrile Neutropenia in the US

Date- February 17, 2023 

Product: Stimufend (biosimilar, pegfilgrastim)

  • The company reported the commercial availability of Stimufend, a biosimilar to Neulasta in the US for patients who are at risk for febrile neutropenia. Stimufend is commercially available in a 6mg/0.6 mL solution in a single-dose pre-filled syringe combined with a passive needle guard
  • Stimufend was approved in the US in Sept 2022 for non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The FDA approval of Stimufend was based on the totality of evidence supporting its biosimilarity to Neulasta
  • The company launched pegfilgrastim biosimilar in a prefilled syringe in France in Oct 2022, following the EC's marketing authorization in Mar 2022

Altos Subsidiary of Alteogen Reports the Completion of Patient Enrollment in P-III Clinical Trial of Eylea Biosimilar for Neovascular Age-related Macular Degeneration

Date- February 22, 2023 

Product: Eylea Biosimilar

  • The company has completed the patient enrolment in an ongoing P-III trial evaluating the efficacy & safety of Eylea Biosimilar (ALT-L9) vs Eylea in 431 patients with neovascular AMD in 12 countries
  • The study was based on the P-I study which showed similar safety & efficacy profiles to the originator product & evaluated PK characteristics. The product's competitiveness from an intellectual property standpoint is further enhanced by the filing & registration of formulation patents related to higher thermal stability & process patents enabling efficient drug substance manufacturing
  • The company plans to complete the product approval in H1’25 while BLA will be submitted to the relevant health authorities in early 2024

EMA Adopts Positive Opinion for Bekemv (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Haemoglobinuria

Date- February 23, 2023 

Product: Bekemv (biosimilar, eculizumab)

  • The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization for Bekemv, a biosimilar candidate referencing Alexion’s Soliris (eculizumab) intended for the treatment of adults and children with PNH
  • The results showed that Bekemv has comparable quality, safety, and efficacy to Soliris. If approved, Bekemv will become the first eculizumab biosimilar to receive EU marketing authorization
  • Bekemv is a recombinant humanized monoclonal IgG2/4k Ab that binds to the human C5 complement protein and prevents terminal complement activation. It will be available as a 300mg concentrate for solution for infusion’

Related Post: Insights+ Key Biosimilars Events of January 2023

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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