Insights+ Key Biosimilars Events of May 2023

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Insights+ Key Biosimilars Events of May 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 May, Celltrion’s Yuflyma (biosimilar, adalimumab) received the US FDA’s approval for multiple indications, and Amneal reported the commercial availability of Fylnetra (biosimilar, pegfilgrastim) in the US. Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023

1. Alvotech Reports an Initiation of AVT05, a Proposed Biosimilar for Simponi and Simponi Aria to Treat Moderate to Severe Rheumatoid Arthritis

Date- May 04, 2023

Product: AVT05

  • The company initiates the P-II confirmatory patient study of AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab) evaluating the efficacy, safety, and immunogenicity of AVT05 (SC) vs EU-approved Simponi in adult patients with mod. to sev. rheumatoid arthritis
  • The primary outcome measures will be to show the comparative efficacy of AVT05 vs Simponi @16wks. based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data
  • Additionally, the company initiates PK study for AVT05 in Jan 2023. Golimumab is a mAb that inhibits tumor necrosis factor-alpha (TNF alpha)

2. Sandoz Reports Real World Study Results of GP2013 (biosimilar, rituximab) for the Treatment of Rheumatoid Arthritis

Date- May 08, 2023

Product: GP2013 (biosimilar, rituximab)

  • The study incl. 2 yr. of RWE evaluating rituximab biosimilar GP2013 vs biologic originator RTX showed that the patients who switched from rituximab to GP2013 experienced positive results & maintained clinical outcomes
  • Satisfactory treatment responses in rituximab-naïve patients & those who underwent a mandatory switch in Norway, drug retention rates in switched vs naïve group @1yr. (84% vs 64%) & 2yr. (60% vs 49%) with no deterioration in disease activity outcomes
  • Disease duration (14 vs 3yrs.), 91% of rituximab-naïve patients received 2000mg GP2013 in 1st cycle; 85% of switched patients received 1000 or 500mg. In the rituximab-naïve group, improvements in most disease activity measure incl. PROs during the 1yr. of treatment and maintained at 2yrs.

3. Celltrion Reports P-III Trial Results of SB3 (biosimilar, trastuzumab) for HER2-Positive Breast Cancer

Date- May 08, 2023

Product: SB3 (biosimilar, trastuzumab)

  • The secondary analysis results from the P-III equivalence trial evaluating SB3 vs Herceptin in patients with HER2+ breast cancer showed no significant differences in event-free or overall survival b/w biosimilar and the reference product
  • The results demonstrated an equivalent efficacy of SB3 to reference trastuzumab based on the risk ratio of bpCR rates, overall cardiac safety profile of SB3 was comparable to reference trastuzumab with the median follow-up duration was 68mos.
  • Median LVEF at baseline was 65% vs 65% with a reduction in LVEF (0.4% vs 0.7%), no incidences of symptomatic congestive heart failure were seen, EFS (20% vs 25%), 5yr. EFS & OS rates (80% vs 75%) and (93% vs 85%)

4. EirGenix Reports the Completion of the P-I Clinical Trial for EG1206A (biosimilar, pertuzumab) to Treat HER2-Positive Breast Cancer

Date- May 08, 2023

Product: EG1206A (biosimilar, pertuzumab)

  • The company has completed the P-I trial (EGC101) in the EU evaluating the second breast cancer biosimilar EG1206A vs Perjeta in patients with HER2+ breast cancer. The clinical data analysis showed that the main test indicators have met the PK bioequivalence standard
  • EG1206A, a biosimilar drug of Perjeta has a unique binding mechanism for HER2 receptors producing a dual blockade effect. The P-III trial of EG1206A is expected to be initiated shortly, estimated that the evaluation of the primary EPs will be completed within 2yrs.
  • To further expedite the introduction of the biosimilar globally, EirGenix has been in talks with global pharmaceutical companies about licensing the marketing rights to EG1206A

5. Sandoz Entered into an Agreement with Just - Evotec Biologics to Develop and Manufacture Multiple Biosimilar

Date- May 09, 2023

Product: N/A

  • The companies collaborated to develop and manufacture multiple biosimilar products. Evotec receives an up front, ~$640M upon the achievement of the development progress & also receives additional fees based on commercial manufacturing progress.
  • Sandoz gets the access to Just-Evotec Biologics’ drug substance development platform and manufacturing technology enabling Sandoz to expand its existing biosimilars pipeline from 15 to ~24 candidates
  • Additionally, Sandoz aims to enhance its early-stage biosimilar pipeline through this collaboration. The collaboration also provides an opportunity to enhance integrated development and manufacturing network

6. Alvotech Entered into an Exclusive Agreement with Polifarma to Commercialize AVT06, a Proposed Biosimilar to Eylea (aflibercept) in Turkey

Date- May 10, 2023

Product: AVT06

  • Under the terms of the agreement, Alvotech will lead the development and manufacture while Polifarma will be responsible for the market registration and commercialization
  • The partnership aims to increase patient access to affordable biologics & also allows Polifarma to diversify its portfolio and strengthen its position in the ophthalmology area
  • AVT06, a recombinant fusion protein, and a biosimilar candidate is currently being studied in clinical development. The company initiated a patient study in July 2022 to evaluate the efficacy, safety, and immunogenicity of AVT06 vs Eylea for adult patients with neovascular (wet) age-related macular degeneration

7. Amgen Files BPCIA Complaint Against Sandoz Over Denosumab Biosimilar

Date- May 10, 2023

Product: Denosumab Biosimilar

  • Amgen filed a BPCIA complaint against Sandoz related to Sandoz’s denosumab biosimilar of Prolia and Xgeva in the District of New Jersey. Amgen also claims that the US FDA approval decision on the biosimilar candidate could come before its relevant patents expire.
  • Amgen is seeking a judgment of infringement and an injunction prohibiting the production and sale of the proposed biosimilar before the patent expiration dates
  • Prolia was the first biologic approved to treat osteoporosis while Xgeva was used to prevent skeletal-related events (e.g., fractures or spinal cord compression) in cancer patients. Both drugs contain denosumab as their active ingredient 

8. Livzon Mabpharm Reports P-I Trial Results of LZM008 (biosimilar, tocilizumab) for Rheumatoid Arthritis

Date- May 15, 2023

Product: LZM008 (biosimilar, tocilizumab)

  • The P-I trial evaluating PK, safety, and immunogenicity parameters of LZM008 (4mg/kg, IV) vs Actemra in a ratio (1:1) in 96 patients
  • The PK characteristics and immunogenicity exhibited by LZM008 were similar to Actemra. The safety profiles were similar in the two groups with mild–mod. adverse effects, the incidence of TEAEs was similar (98% vs 100%), 8% vs 13% had TEAEs of grade 3 or worse & no serious AEs or TEAEs leading to discontinuation of treatment or death while all grade 4 TEAEs resolved after day 36
  • Additionally, patients had positive anti-drug Ab (2% vs 6%), 1 patient was positive for neutralizing Ab in the reference product group

9. Boan Biotech Reports the Completion of Patient Enrolment in the P-III Clinical Trial of BA5101, a Proposed Biosimilar Dulaglutide

Date- May 15, 2023

Product: BA5101

  • The patient enrolment has been completed in the P-III trial evaluating BA5101, its proposed biosimilar to Eli Lilly’s Trulicity (dulaglutide) in patients with insufficiently controlled type 2 diabetes mellitus
  • The P-I trial in China showed that BA5101 was highly similar PK characteristics, safety & immunogenicity with Trulicity indicating that it has clinical similarity with the reference product & the results were published in the Journal of Expert Opinion on Biological Therapy, Taylor & Francis
  • In preclinical studies, BA5101 was found to be highly similar to Trulicity in terms of biological activities & physicochemical properties. BA5101 is used for glycemic control in adults with insufficiently controlled T2D

10. Amneal Reports the Commercial Availability of Fylnetra (biosimilar, pegfilgrastim) in the US

Date- May 17, 2023

Product: Fylnetra (biosimilar, pegfilgrastim)

  • The company launch Fylnetra, a biosimilar referencing Neulasta in the US making it the sixth biosimilar for febrile neutropenia. The biosimilar was developed in collaboration with Kashiv Biosciences
  • The company focuses to provide high-quality biosimilars to the global markets over the coming years. The biosimilar product is intended to lower the incidence of inf. as manifested by FN in patients with non-myeloid malignancies on myelosuppressive anticancer drugs
  • Fylnetra is supplied as a 6mg/0.6mL preservative-free solution in single-dose prefilled syringes for SC inj. The US FDA approved Fylnetra, a leukocyte growth factor based on data demonstrating a high degree of similarity over reference products with no clinical differences

11. Boehringer Ingelheim’s Cyltezo Pen Receives the US FDA’s Approval for Cyltezo, an Interchangeable Biosimilar to Humira

Date- May 22, 2023

Product: Cyltezo

  • The US FDA has approved Cyltezo Pen, an autoinjector option of Cyltezo (the US FDA-approved Interchangeable biosimilar to Humira)
  • Additionally, 40mg/0.8mL pre-filled Cyltezo Pen will be available in two, four, and six-pack options on July 1, 2023. Cyltezo was initially approved as a pre-filled syringe, indicated to treat multiple chronic inflammatory diseases incl.  RA, JIA, CD, and PsO
  • Additionally, Cyltezo Pen features a one-button, 3-step activation with 100% drug visibility and a protected needle. In 2021, Cyltezo became the first approved interchangeable biosimilar to treat certain inflammatory diseases

12. Janssen and Amgen Settle Patent Dispute of Stelara Biosimilar

Date- May 23, 2023

Product: Stelara Biosimilar

  • J&J has settled its patent infringement lawsuit against Amgen over a proposed ustekinumab biosimilar referencing Stelara. Amgen will be allowed to sell its ustekinumab biosimilar no later than Jan 2025
  • Amgen highlighted the preliminary results from a P-III study which showed no clinical differences b/w ABP 654 and Stelara in adults with mod. to sev. PsO
  • Ustekinumab, an anti-IL-12/IL-23 Ab drug indicated to treat PsO, PsA, CD, and UC. Acc. to a complaint filed last Nov 2022, J&J argued that Amgen’s ustekinumb biosimilar ABP 654 would infringe two patents

13. Celltrion’s Yuflyma (biosimilar, adalimumab) Receives the US FDA’s Approval for Multiple Indications

Date- May 25, 2023

Product: Yuflyma (biosimilar, adalimumab)

  • The US FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira for the treatment of 8 conditions: RA, JIA, PsA, AS, CD, UC, PsO, and HS. Yuflyma is a high-concentration (100mg/mL) & a citrate-free adalimumab biosimilar
  • The approval was based on a comprehensive data package of preclinical, clinical, and analytical studies which showed that the biosimilar and reference products were similar with regard to efficacy, safety, PK, and immunogenicity after 24wks. and 52wks. of treatment
  • Yuflyma is supplied as 40mg/0.4mL in single-dose prefilled autoinjectors (Yuflyma AI) and single-dose prefilled syringes. The product is expected to be available in July 2023 in the US

14. Sandoz Reports the EMA Acceptance of MAA for Proposed Biosimilar Denosumab

Date- May 25, 2023

Product: Prolia & Xgeva

  • The EMA has accepted the MAA for the proposed biosimilar denosumab (Prolia & Xgeva) indicated for treating multiple indications incl. osteoporosis in postmenopausal women, men with high fractures risk & treatment-induced bone loss
  • The application was based on comprehensive analytical & clinical data incl. data from a P-I PK/PD similarity study in healthy volunteers and the P-I/III study (ROSALIA) study which showed a similarity b/w denosumab & reference medicine in terms of PK, PD, efficacy, safety & immunogenicity in the respective study populations
  • The company continues to build a biosimilars portfolio to increase patient access to high-quality, affordable biologics & generate savings for healthcare systems

15. Lupin Collaborated with Enzene Biosciences to Launch Cetuximab in India

Date- May 30, 2023

Product: Cetuximab

  • The companies collaborated to launch Cetuximab, the first biosimilar developed for Cetuximab in India to treat patients with head & neck cancer. Cetuximab is available as a 100mg vial
  • The DCGI has approved cetuximab due to its efficacy in treating head and neck cancer incl. SCCHN. In 2009, Eli Lily and Merck’s Erbitux (cetuximab) have been approved by the US FDA for metastatic colorectal cancer and head and neck cancer
  • Lupin develops & commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in ~100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), EU, and Middle East regions

16. Samsung Bioepis Receives EC’s Marketing Authorization for Epysqli (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Hemoglobinuria

Date- May 31, 2023

Product: Epysqli (biosimilar, eculizumab)

  • The EC has granted marketing authorization for Epysqli, a biosimilar referencing Soliris (eculizumab) for the treatment of adult and children’s patients with PNH
  • The approval was based on a totality of evidence incl. analytical, in vitro non-clinical data, and clinical data. The P-III study showed an equivalent clinical efficacy of Epysqli (first approved hematology biosimilar) over eculizumab after evaluating LDH in PNH patients
  • Additionally, the company has seven biosimilars approved for use in the EU incl. Benepali, an anti-inflammatory biosimilar to Enbrel, and Imraldi, a biosimilar referencing Humira

Related Post: Insights+ Key Biosimilars Events of April 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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