Insights+ Key Biosimilars Events of November 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 November, Samsung Bioepis presented two P-III studies results of SB11 (biosimilar, ranibizumab) for neovascular age-related macular degeneration at AAO 2022, STADA and Xbrane received EC’s marketing authorization of Ximluci (biosimilar, ranibizumab) for retinal disorders. Our team at PharmaShots has summarized 13 key events of the biosimilar space of November 2022
Date- November 01, 2022
Product: BAT2306
- The company initiated the P-III clinical study evaluating the efficacy and safety of BAT2306 vs Cosentyx in patients with mod. to sev. PsO
- Secukinumab is a human IgG1κ mAb that binds to the protein interleukin (IL)-17A. The company intends to submit the BLA/MAA to the NMPA, US FDA, EMA, and other regulatory bodies with the request for approval for all of the available indications
- The company is currently developing multiple additional biosimilar products for the global market incl. biosimilar versions of Actemra, Simponi, Stelara, and Nucala. Additionally, Qletli (biosimilar, adalimumab) and Pobevcy (biosimilar, bevacizumab) have been approved in China
Date- November 02, 2022
Product: SB11 (biosimilar, ranibizumab)
- The 2 studies determine the ranibizumab biosimilar impact on patient outcomes. The post hoc analysis of a P-III trial determines the baseline factors to predict visual acuity & anatomical outcomes with the biosimilar vs Lucentis & efficacy outcomes after 1yr. of SB11 vs Stelara
- In a linear regression model, a lower gain in BCVA of 1.9 letters and a greater CST reduction of 12.6mcm @52wk., similar therapy effects were observed b/w SB11 & reference product in the subgroup analysis
- The correlation analysis from the P-III trial of SB11 vs Lucentis (ITV, 0.5mg, q4w) showed a low immunogenicity profile & similar to the reference product, the cumulative incidence of an ADA+ response was low with the immunogenicity result (4.2% vs 5.5%) @52wk.
3. Intas Entered into an Exclusive License Agreement with Syna to Commercialize Biosimilar LB-0702
Date- November 03, 2022
Product: LB-0702
- The companies collaborated to commercialize the biosimilar drug LB-0702 to treat pathologies in the field of haematology. The clinical trials for LB-0702 are expected to be initiated in 2023 with the support of its partner Leanbio and Reig Jofre
- Intas to get an exclusive license right to commercialize LB-0702 globally while Syna will be responsible to develop and manufacture LB-0702 and supply the product to Intas and its affiliates
- Leanbio's technology platforms will be used to develop and manufacture the biosimilar, along with Reig Jofre's technology production expertise at its new manufacturing plant in Barcelona which specializes in sterile injectables and freeze-dried biopharmaceuticals
Date- November 07, 2022
Product: Biosimilar Insulin Glargine
- Lannett entered into a patent license agreement with Ypsomed and its strategic partner within HEC for a pen injector delivery device to be used for its insulin glargine and insulin aspart development program
- In return for its financial contribution, Lannett and HEC will receive a sub-license under the arrangement b/w Ypsomed and Sanofi-Aventis Deutschland GmbH which was the owner of several patents relating to the pen injector device
- The company is expected the results at the end of 2022 with an expected filing of the BLA for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus in 2023 and the product is expected to be launched in H1’24
5. Dong-A ST Signed an Exclusive License Agreement with Polifarma for NESP Biosimilar DA-3880
Date- November 09, 2022
Product: NESP Biosimilar DA-3880
- Dong-A ST will receive up front and developmental/commercial milestones & be responsible to supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings. The companies collaborated for NESP biosimilar DA-3880
- Polifarma to get an exclusive license right for the development and commercialization of DA-3880 in Türkiye, Brazil, and Mexico. DA-3880 is an ARANESP/NESP biosimilar indicated for the treatment of anemic patients with chronic renal failure or those undergoing CT
- In 2014, Dong-A ST entered a license-out agreement with Sanwa Kagaku Kenkyusho for the development and commercialization of DA-3880 in Japan
6. Alvotech to Present Switching Study Results of AVT02, a Proposed Biosimilar to Humira at ACR 2022
Date- November 10, 2022
Product: AVT02
- The company highlighted the 2 posters on the switching study for ATV02. The 1st poster highlighted the interchangeability b/w AVT02 and Humira. The 2nd poster highlighted ex vivo comparative immunogenicity assessment to assess immunogenicity in patients with chronic PsO
- The study focuses to determine the PK, immunogenicity, efficacy & safety in patients undergoing repeated switches b/w Humira and AVT02
- AVT02 is a mAb & was approved in the EU, the UK, Switzerland, Norway, Iceland, Lichtenstein & Canada. In Feb 2022, the US FDA accepted the BLA of ATV02 which incl. new data supporting interchangeability b/w ATV02 and Humira & is currently under the US FDA’s review
Date- November 10, 2022
Product: Boyoubei (biosimilar, denosumab)
- The NMPA has approved Boyoubei, a first denosumab biosimilar referencing Prolia/Xgeva for postmenopausal women with osteoporosis who are at a high risk of fractures. The product has been developed by Luye Pharma with its subsidiary Boan Biotech
- Boyobei is also being developed for markets outside of China, incl. the EU & US, and will seek marketing approval globally
- The evidence showed that Boyoubei was bioequivalent to the originator drug, the quality, safety, and efficacy of the two drugs are highly similar with no clinical difference. Patients treated with Boyoubei for 6mos. or 1yr. showed a higher BMD in the lumbar spine, hip, and femoral neck, lower levels of biochemical markers of bone turnover, incl. CTX & P1NP
Date- November 11, 2022
Product: Ximluci (biosimilar, ranibizumab)
- The EC has granted marketing authorization for Ximluci, a biosimilar referencing Lucentis with an expected launch in selected European markets early in 2023
- The marketing authorization was based on a comprehensive comparative analytical assessment & P-III study in 580 patients evaluating Ximluci which demonstrated equivalent efficacy and comparable safety to reference Lucentis
- The EC’s centralized marketing authorization is valid in all 27 EU member states, Iceland, Norway & Liechtenstein. In July 2018, STADA & Xbrane collaborated for the development & manufacturing of the finished product where STADA got the commercial rights to the biosimilar across all territories
9. Organon Launches Ontruzant (biosimilar, trastuzumab) for the Treatment of Gastric Cancer
Date- November 14, 2022
Product: Ontruzant (biosimilar, trastuzumab)
- The company reported the commercial availability of Ontruzant, a biosimilar of Herceptin to treat adults diagnosed with metastatic gastric cancer & other indication
- Organon's collaborator Samsung Bioepis has developed and produced Ontruzant as well as the other biosimilars in its portfolio i.e., Aybintio, Hadlima, Brenzys, and Renflexis
- The company’s goal is to provide more affordable treatment options to the patients to use Ontruzant & continues to support the mission “Here for Her Health"
10. Alvotech and Cipla Receive Marketing Authorization for AVT02 (biosimilar, adalimumab) in Australia
Date- November 14, 2022
Product: AVT02 (biosimilar, adalimumab)
- The company reported that Cipla has received marketing authorization for Alvotech's AVT02, a high-concentration low-volume biosimilar to Humira (adalimumab) by the Therapeutic Goods Administration of Australia
- Alvotech’s biosimilar will be available as a 40mg/0.4mL and 80mg/0.8mL solution in a pre-filled syringe and 40mg/0.4mL solution in a pre-filled pen
- AVT02 is a mAb that inhibits tumor necrosis factor & will be marketed as Ciptunec and Ardalicip. The biosimilar has been approved in the EU, Norway, Iceland, Lichtenstein, the UK, and Switzerland as Hukyndra; and in Canada and Saudi Arabia as Simlandi & is currently under review in multiple countries, incl. US
11. Amneal Launches Releuko (biosimilar, filgrastim) for the Treatment of Neutropenia
Date- November 22, 2022
Product: Releuko (biosimilar, filgrastim)
- The company reported the commercial availability of Releuko, a biosimilar referencing Neupogen for neutropenia. Releuko was being developed in collaboration with Kashiv Biosciences
- Releuko was approved in the US in Mar 2022 & showed that the biosimilar & reference products were highly similar with no clinical differences & are available in single-dose vials & prefilled syringes containing 300/480mcg of filgrastim-ayow in a preservative-free solution
- The product is indicated to reduce the incidence of inf.; duration of neutropenia & neutropenia-related clinical sequelae for non-myeloid malignancies; time to neutrophil recovery & duration of fever for AML; incidence & duration of sequelae of sev. neutropenia for congenital neutropenia‚ CyN‚ or IN
Date- November 23, 2022
Product: Rezvoglar
- The US FDA has approved Rezvoglar, a second interchangeable biosimilar insulin product to Lantus (insulin glargine) for diabetes mellitus, based on Semglee which the US FDA approved on July 28, 2021. Rezvoglar (SC, QD) is available in 3mL prefilled pens
- The biosimilar is a long-acting human insulin analog that can help improve glycemic control in adult and pediatric patients with T2D. The company has previously approved insulin glargine-aglr as a biosimilar to insulin glargine on Dec 17, 2021
- Greater availability of biosimilar and interchangeable insulin products may provide more treatment options for patients with the potential to lower treatment costs and allow greater access to more individuals
Date- November 26, 2022
Product: BI 695501 (biosimilar, adalimumab)
- The P-III (VOLTAIRE-X) trial evaluates BI 695501 vs Humira in 259 patients at 49 sites across EU & North America
- PK equivalence was demonstrated with highly similar efficacy, clinical outcomes, and immunogenicity, comparable safety was observed who received adalimumab RP continuously or who switched b/w adalimumab RP and BI 695501
- At 32wk., 85% & 79% of patients in switching & continuous groups had a 75% reduction in PASI scores; 70% & 65% had a static sPGA response of 1 or lower (clear or almost clear); 90% & 95% developed anti-drug Abs; 41% & 42% neutralizing Abs; TEAEs related to study treatment (12% & 18%); treatment discontinuation due to TEAEs in 0.8% & 1.7%, PASI scores were highly similar across the entire trial period, respectively
Related Post: Insights+ Key Biosimilars Events of October 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.
