Insights+ Key Biosimilars Events of September 2022
- 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 September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the US FDA's approval for non-myeloid malignancies, Sandoz reported P-I/III (ROSALIA) trial results for Biosimilar Denosumab to treat postmenopausal women with osteoporosis. Our team at PharmaShots has summarized 16 key events of the biosimilar space of September 2022
Date- September 06, 2022
Product: Stimufend (biosimilar, pegfilgrastim)
- The US FDA has approved Stimufend, a biosimilar referencing Neulasta for non-myeloid malignancies who received myelosuppressive anti-cancer drugs associated with the incidence of FN. The product will be available in the US as a prefilled syringe & in an on-body injector in early 2023
- The approval was based on a comprehensive data package & totality of evidence that showed comparable safety & efficacy of Stimufend vs Neulasta with no clinical differences
- The company received the EC's marketing authorization for Stimufend in 2022 & is expected to launch its pegfilgrastim biosimilar in a prefilled syringe in the EU. In addition to Stimufend, the BLA for tocilizumab biosimilar & adalimumab are currently under the US FDA’s review
Date- Sep 07, 2022
Product: Prolia, Xgeva, Simponi & Eylea
- The companies collaborated to commercialize five of Alvotech’s proposed biosimilars in the Philippines. Prolia, Xgeva, Simponi & Eylea are among the biosimilars planned under this agreement. Additionally, 2 suggested biosimilars for immunology and oncology are also included
- The agreement enhances Multicare’s oncology, rheumatology, gastroenterology, and ophthalmology, a portfolio that consists of 3 biosimilar candidates & ~50 generic therapies
- Lupin’s subsidiary Multicare will file for marketing approval and will be responsible for the distribution & commercialization of the biosimilars. The reference products are used to treat diseases related to ophthalmology, cancer, immunology, and bone disease
Date- Sep 07, 2022
Product: SB5 (biosimilar, adalimumab)
- The company reported the 3yr. follow up results from the study evaluating adalimumab biosimilars in 1059 patients with psoriasis
- The results showed the safety and effectiveness of SB5 in patients with psoriasis who have started or transitioned from reference adalimumab, persistence rate after 3yr. therapy was 72.1%, treatments discontinued in 25.1%, and mean (± SD) SB5 treatment duration was 19.3mos. ± 9.1, cumulative persistence rate of 1/2/3yr. (79.7%/73.5%/72.1%), respectively
- The therapy has been the EU in Aug 2017, under the brand name Imraldi as a biosimilar to Humira. Biogen gets an exclusive marketing right to Imraldi along with Benepali and Flixabi in the EU
4. EpiVax Raised $2M Funding from the US FDA for Immunogenicity Testing of Biosimilars
Date- Sep 12, 2022
Product: N/A
- The US FDA has awarded the company a $2M grant over 2yrs. for investigating the immunogenicity of biosimilars
- To enhance the development of biosimilar candidates and evaluate the interchangeability of biosimilars, the analyses will validate a method for immunogenicity risk assessment of host cell proteins (HCPs)
- The funding will help EpiVax to assess in silico tools for screening and triaging HCPs to induce an unwanted immune response in patients receiving a biosimilar. The preclinical validation of in silico tools improved the safety of biological drugs and accelerates the assessment process of immunogenicity risk for biosimilars
5. Regeneron Seeks Expedited Trial for Aflibercept Biosimilar
Date- Sep 13, 2022
Product: Aflibercept Biosimilar
- In Aug 2022, Regeneron filed a BPCIA complaint against Mylan in West Virginia alleging infringement of 24 patents related to Eylea (aflibercept). Regeneron filed a motion just two days after submitting its complaint asking for an expedited status conference and a trial date no later than June 2023
- Regeneron is requesting a quick trial of only 10mos. after bringing its complaint to benefit from the statutory permanent injunction provided by 35 U.S.C. 271(e)(4) (D)
- Regeneron may submit a motion for preliminary injunction based on a finding of potential infringement of a valid patent and evaluation of the standard criteria for an injunction filed within 180 days of Mylan's notification of commercial marketing
6. Samsung Bioepis and Genentech Settles Patent Dispute of SB8, a Proposed Biosimilar of Avastin
Date- Sep 15, 2022
Product: SB8
- The companies have filed a joint stipulation of dismissal of their BPCIA patent litigation for the Avastin (bevacizumab) dispute. In June 2020, Genentech filed a suit against Samsung Bioepis alleging infringement of 14 patents related to bevacizumab
- Under the Settlement Agreement, the companies will voluntarily dismiss all claims & counterclaims in Avastin-related patent disputes allowing Samsung Bioepis’ biosimilar to be prescribed for all the same indications as the reference drug
- The companies have ended 2yr. legal battle over the submission of marketing approval for SB8, an Avastin biosimilar in the US. SB8 will now be able to be prescribed to people with peritoneal cancer & epithelial ovarian cancer
7. Prestige Biopharma Withdraws the MAA for HD201 (biosimilar, trastuzumab) from the EMA
Date- Sep 16, 2022
Product: HD201 (biosimilar, trastuzumab)
- The company withdrew its MAA for HD201 (biosimilar, trastuzumab) that was submitted to the EMA and plans to re-submit the MAA with supplement data of additional tests & analysis
- In May 2022, Prestige requested a re-examination of its MAA for the HD201 after receiving a negative opinion from the EMA’s CHMP due to variance in the range of acceptance for the criteria of analytical comparability b/w clinical testing batch & commercial production batch of HD201
- Currently, the MAA for HD201 is under Health Canada and MFDS Korea’s review & will submit an MAA to the US FDA at the end of 2022. Prestige focuses on the reapplication of the MAA to EMA for HD201
8. STADA and Xbrane Receive EMA’s CHMP Positive Opinion for Ximluci (biosimilar, ranibizumab)
Date- Sep 16, 2022
Product: Ximluci (biosimilar, ranibizumab)
- The EMA’s CHMP has adopted a positive opinion for Ximluci, a biosimilar referencing Lucentis for wet AMD, DME, PDR, RVO & visual impairment due to CNV. The biosimilar will be available on the UK market shortly
- The opinion was based on the P-III study to evaluate Ximluci which showed a comparable safety & efficacy of Ximluci vs Lucentis for wet AMD. The EC’s centralized marketing authorization will be valid in all 27 EU member states, Iceland, Norway & Liechtenstein
- If Ximluci is approved, it will 1st a biosimilar candidate authorized through the partnership & will be developed under Xlucane. In a 2018 agreement with Xbrane, STADA will hold the marketing authorizations & commercial rights to the biosimilar across all territories incl. EU, the US & other countries
Date Sep 17, 2022
Product: SAR342434
- The P-I study evaluates SAR342434 (0.3-U/kg, SC) vs insulin lispro (Humalog) in 36 healthy male patients with T1D or T2D
- The results showed that SAR-Lis had similar PK exposure and glucose pharmacodynamic activity compared with Japanese-approved insulin lispro formulation supporting the use of SAR-Lis as a biosimilar product, no serious AEs, AEs of special interest, or TEAEs leading to treatment discontinuation
- Additionally, a few clinically significant abnormalities in laboratory tests and ECG parameters were observed with no notable difference b/w SAR-Lis and the reference Humalog. SAR-Lis was the first insulin lispro biosimilar authorized in the EU in 2017 and in Japan in 2020
Date- Sep 19, 2022
Product: Biosimilar Denosumab
- The P-I/III (ROSALIA) trial evaluating biosimilar denosumab in 527 postmenopausal women with osteoporosis for ~78wks. The trial met its 1EPs i.e., biosimilar denosumab had similar PD, PK, safety, efficacy & immunogenicity over reference medicine in the respective indications
- In June 2022, the high-concentration formulation 100mg/mL (HCF) of Sandoz's biosimilar adalimumab application has been accepted for review by the EMA & US FDA
- Denosumab is a human mAb that binds to RANKL protein & is indicated for osteoporosis in postmenopausal women, in men who are at high risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer & giant cell tumor of the bone
11. Alvotech and STADA Launch Hukyndra (biosimilar, adalimumab) in Switzerland
Date- Sep 23, 2022
Product: Hukyndra (biosimilar, adalimumab)
- Alvotech & STADA launched Hukyndra, a biosimilar to Humira (adalimumab) & marketed by Spirig HealthCare AG, STADA’s subsidiary in Switzerland
- Hukyndra is a high-concentration, low-volume, citrate-free formulation that is available in 80mg/0.8mL & 40mg/0.4mL in a self-administration safety device & 40mg/0.4mL in a pre-filled auto-inject pen. Under the collaboration with STADA, Alvotech’s strength will use for biosimilars development & manufacturing platform to broaden patient access to cost-effective biologics across the EU
- Hukyndra was approved in the EU & other countries as Simlandi & is under review in multiple countries, incl. the US. The collaboration b/w Alvotech & STADA in the EU includes Hukyndra & 6 biosimilar candidates across autoimmunity & other indications
Date- Sep 24, 2022
Product: Enoxaparin Biosimilar
- The P-I crossover, balanced, single-dose PD study evaluates enoxaparin sodium biosimilar Cloti-Xa vs Clexane in 24 male healthy volunteers aged 35yrs. After the administration of the study drugs, many blood samples were obtained over the next 24hrs.
- The results showed a similar PD & PK profiles of enoxaparin sodium biosimilar Cloti-Xa vs reference Clexane & Lovenox & also showed anti-factor Xa and anti-factor IIa activity within predefined bioequivalence margins, 90% CIs for TFPI & aPTT were within the bioequivalence margins excl. AUECt for aPTT
- Both biosimilar & reference Clexane were well-tolerated with no serious AEs. Enoxaparin sodium is low-molecular-weight heparin & an antithrombotic medication indicated for arterial & VTE
Date- Sep 26, 2022
Product: Vegzelma (biosimilar, bevacizumab)
- The US FDA has approved Vegzelma, a biosimilar to Avastin (bevacizumab) for 6 types of cancer i.e., mCRC, recurrent or metastatic nsq. NSCLC, recurrent GBM, metastatic RCC, persistent, recurrent, or metastatic cervical cancer; and EOC, fallopian tube, or PPC
- The approval was based on the totality of evidence incl. the P-III trial of Vegzelma in patients with metastatic or recurrent nsq. NSCLC. The results showed that the therapy was highly similar to the reference bevacizumab in terms of efficacy, safety & PK
- Vegzelma is the third oncology biosimilar to receive approval from the US FDA, following the approval of Truxima & Herzuma. Vegzelma was approved in the EU in August 2022 while UK & Japan in Sept 2022
Date- Sep 27, 2022
Product: SB15 and SB11
- The company highlighted the results from its ophthalmology biosimilar portfolio. In a 32wk. interim analysis from the P-III study, SB15 a proposed biosimilar to Eylea showed equivalent efficacy & comparable safety, immunogenicity & PK profile over reference aflibercept in nAMD
- The post-hoc analysis from the P-III study of SB11, a biosimilar to Lucentis showed a low immunogenicity profile with no correlation b/w immunogenicity and clinical outcomes
- Other post-hoc analyses of the P-III study of SB11 showed that baseline age, BCVA, and CST were determined to be predictive of visual acuity & anatomical outcomes, similar results were shown from a post-hoc analysis of multiple trials along with an equivalent clinical efficacy
15. Biogen Reports the EMA Acceptance of MAA for BIIB800 (biosimilar, tocilizumab)
Date- Sep 30, 2022
Product: BIIB800 (biosimilar, tocilizumab)
- The EMA has accepted the MAA for BIIB800, a biosimilar referencing RoACTEMRA (tocilizumab). RoACTEMRA is indicated as an IV formulation for RA & JIA
- The MAA was based on the P-III trial evaluating BIIB800 vs RoACTEMRA in 621 patients with mod. to sev. RA with inadequate response to methotrexate which showed that biosimilar BIIB800 was equivalent to the reference tocilizumab in terms of efficacy, PK, safety & immunogenicity profile
- On April 2021, Biogen & Bio-Thera collaborated to develop, manufacture & commercialize BIIB800 where Biogen gets exclusive regulatory, manufacturing & commercial rights for BIIB800 in all countries excl. China (incl. Hong Kong, Macau & Taiwan)
Date- Aug 31, 2022
Product: Biosimilar Insulin Glargine
- The company has completed the patient dosing in the PK and PD study of biosimilar insulin glargine in the healthy volunteer. The biosimilar is being co-developed with its strategic alliance partners within HEC
- Additonally, no serious AEs were reported & further results are expected to be available at the end of 2022
- The company will file the BLA for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus Solostar in 2023 & the product is expected to be available in H1’24
Related Post: Insights+ Key Biosimilars Events of August 2022
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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.
