Insights+ Key Biosimilars Events of October 2022

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Insights+ Key Biosimilars Events of October 2022

Insights+ Key Biosimilars Events of October 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 October, Similis Bio entered into a development and license agreement with Blau Farmaceutica to co-develop four biosimilar programs, Shanghai Henlius reported P-III placebo-controlled trial results of HLX01 (biosimilar, rituximab) for active rheumatoid arthritis. Our team at PharmaShots has summarized 11 key events of the biosimilar space of October 2022

1. Amneal Launches Alymsys (biosimilar, bevacizumab) in the US

Date- October 04, 2022     

Product: Alymsys (biosimilar, bevacizumab)

  • The company launches Alymsys, a biosimilar referencing Avastin to provide additional access and options to patients and physicians for affordable oncology treatments
  • Alymsys is a vascular endothelial growth factor inhibitor used in oncology that was developed by mAbxience with an experience in the development, manufacture, and commercialization of biopharmaceuticals
  • Additionally, the company also seeks to increase the number of molecules in its biosimilar portfolio and has a growing line of branded pharmaceutical products with a primary focus on endocrine and central nervous system disorders

2. Samsung Bioepis and Momenta Highlighted Two Posters of Aflibercept Biosimilars at AAO 2022

Date- October 06, 2022     

Product: Aflibercept Biosimilars

  • The company highlighted 2 posters of the P-III trials evaluating SB15 (developed by Samsung Bioepis) & MYL-1701P (developed by Momenta & Viatris) vs Eylea in a ratio (1:1) in 449 treatment-naive nAMD patients & 355 patients
  • In a 32wk. analysis of SB15, the 1EPs were found to be equivalent with no new safety signals, and incidence & severity of TEAEs b/w 2 products were similar ~32wk. while immunogenicity & PK profiles were also similar
  • The (INSIGHT) Study on MYL-1701P showed the therapeutic equivalence b/w drugs, TEAEs were comparable for the biosimilar & reference product with no differences regarding antidrug Abs, patients who had gains and losses in visual acuity were similar b/w the treatment arms & was safe & well tolerated  

3. Shanghai Henlius Reports P-III Placebo-Controlled Trial Results of HLX01 (biosimilar, rituximab) for Active Rheumatoid Arthritis

Date- October 10, 2022     

Product: HLX01 (biosimilar, rituximab)

  • The P-III placebo-controlled trial evaluates rituximab biosimilar HLX01 (1000mg, IV) + methotrexate vs PBO in a ratio (2:1) in 275 biologic-naïve patients with active RA across 40 centers in China
  • The combination therapy was superior to PBO in clinical outcomes with a comparable safety profile, ~40% with RA may not respond to methotrexate, ACR20 response rate @24wk. (61% vs 36%), patients were switched from PBO to HLX01 @24wk., the response rate increased with greater decreases in measures of disease activity while pain, physical function & mental health indicators also improved
  • ADAs (6.0% vs 3.3%) before 24wk.; 3.8% vs 8.8% who continued with biosimilar & switched to the biosimilar from PBO after 24wk., TEAE (83% vs 80%), treatment discontinuation due to TEAEs (7.1% vs 4.3%)

4. Celltrion Reports P-II Study Results of Herzuma (biosimilar, trastuzumab) for the Treatment of HER2-Positive Breast Cancer

Date- October 15, 2022     

Product: Herzuma (biosimilar, trastuzumab)

  • The P-II study evaluating trastuzumab biosimilar + TPC in 109 patients with HER2+ MBC who had failed 2 HER2-directed chemotherapies
  • The results showed ORR (18.7%) after the median follow-up of 13.3mos., m-PFS was 4.6mos. & m-OS was 18.6mos. In the subgroup analyses, m-PFS (5.6 vs 4.2mos. in historical control) and in patients who had a response duration to prior anti-HER2 therapy of ≥6mos. (5.8 vs 3.3mos.), patients with liver metastasis had a non-statistically significant shorter PFS, was effective and safe & showed comparable efficacy & safety to the reference product
  • The study highlighted the genetic biomarkers & showed DoR to prior anti-HER2 therapy,  patients with mutations of PIK3CA (23%) or ERBB2 (7.0%) had shorter PFS

5. Alvotech’s Partner Fuji Pharma Report Submission of Application to MHLW for Approval of First Biosimilar Candidate in Japan

Date- October 17, 2022     

Product: N/A

  • Alvotech commercialization partner Fuji Pharma submitted an application to MHLW for marketing approval of the first biosimilar candidate developed under an exclusive collaboration
  • In Nov 2018, the companies collaborated for the commercialization of Alvotech’s biosimilar portfolio in Japan & has expanded its partnerships for an additional biosimilar candidate in Japan in Dec 2020 and Feb 2022 to cover 6 proposed biosimilars in Japan
  • In Feb 2022, Fuji get exclusive commercial rights to an undisclosed biosimilar that is currently in early phase development while Alvotech will receive an upfront & will be eligible for milestones tied to development progression & share of the in-market sales

6. Biocon Entered into an Out-Licensing Agreement with Yoshindo to Commercialize bUstekinumab and bDenosumab in the Japan

Date- October 17, 2022     

Product: bUstekinumab and bDenosumab

  • Biocon Biologics to receive an up front license fee along with an additional fee upon achievement of development milestones over the next few years
  • Yoshindo to get exclusive commercialization right in Japan for bUstekinumab and bDenosumab which was developed and manufactured by Biocon Biologics. The clinical trials for these two assets initiated in 2022, and include both P-I & III trials along with robust pre-clinical CMC packages
  • Ustekinumab, a biosimilar referencing Stelara is a mAb & is indicated to treat multiple autoimmune conditions, incl. psoriasis, CD, UC, PsO, and PsA. Denosumab, a biosimilar referencing Prolia is a mAb & is used for the treatment of osteoporosis

7. Alvotech & JAMP Pharma Expands its 2020 Agreement for Two Biosimilar Candidates in Canada

Date- October 19, 2022     

Product: AVT16 & AVT33

  • The collaboration expanded to add 2 biosimilar candidates to bring more affordable biologics to patients from Alvotech’s pipeline i.e., AVT16 for immunology & AVT33 for oncology. The companies have signed the agreement in Jan 2020 for 5 biosimilar candidates in the Canadian market
  • JAMP Pharma to get exclusive commercialization rights for Alvotech’s biosimilars in Canada & uses JAMP Pharma’s strong sales, marketing capabilities, and experience for new biosimilars. Alvotech will lead the development & commercialization of the biosimilar candidates.
  • The companies launched a patient support program i.e., BIOJAMP & JAMP Care that provides access to patients and caregivers transitioning to lower-cost biosimilar therapies

8. Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Initiative

Date- October 20, 2022     

Product: N/A

  • The government of Saskatchewan will implement a switching or transitioning policy to expand the use of biosimilar medicines under its public drug programs and reinvest the savings to support patient access to public drug coverage and new drug benefits
  • Saskatchewan joined 5 provinces and 1 territory in implementing a biosimilar switching policy, allowing for reference products to be switched out for biosimilars and lowering drug costs for the province’s public health plan
  • Patients who are covered by the Saskatchewan Drug Plan and received biological drugs will have to switch to a biosimilar version of their medicine by April 2023 to treat conditions incl. arthritis, diabetes, IBD & psoriasis

9. Rani Therapeutics Highlighted RT-111 Development Program for Multiple Indications

Date- October 24, 2022     

Product: RT-111

  • The company reported the preclinical development of RT-111, a RaniPill GO capsule containing a biosimilar of Stelara (ustekinumab)
  • The results from part 1 of the P-I study for RT-102 meeting all of the EPs & were well-tolerated. RT-102 orally delivered 20 & 80µg of PTH with 300-400% greater bioavailability over Forteo (20µg, SC). The repeat-dose results from Part 2 of the P-I study for RT-102 for the treatment of osteoporosis are expected in Q4’22
  • The company plans to initiate in vivo studies with a fully-autonomous RaniPill HC in Q4’22 to deliver payloads of ~20mg with high bioavailability. The P-II study of RT-102 & P-I study with three pipeline molecules is expected to be initiated in 2023

10. Similis Bio Entered into a Development and License Agreement with Blau Farmaceutica to Co-Develop Four Biosimilar Programs

Date- October 25, 2022     

Product: N/A

  • Similis Bio collaborated with Blau Farmacêutica for 4 biosimilar assets targeted indications in oncology, inflammation, and blood disorders
  • Similis Bio uses its expertise and experience to support programs & provides additional treatment options for debilitating diseases patients & will be responsible to provide full processes and associated IP for tech transfer to Blau incl. cell lines, analytical data, and methodologies, and upstream/downstream processes
  • Blau gets exclusive rights globally and intends to sell in America by itself and partner with local organizations in other regions & will be responsible for domestic development and seeking regulatory approval in Latin American markets

11. Biogen Requests a Preliminary Injunction in BPCIA Case Against Sandoz Proposed Biosimilar of Tysabri (natalizumab)

Date- October 27, 2022

Product: Tysabri (natalizumab)

  • In its BPCIA case against Sandoz regarding Sandoz's proposed Tysabri biosimilar, Biogen asks for a preliminary injunction (natalizumab). The joint stipulation of the parties and the proposed schedule for a motion for a preliminary injunction were addressed in a sealed order that the Court issued on Oct 20, 2022
  •  A redacted version of Biogen's 107-page sealed complaint against Sandoz was recently released. Biogen claims that Sandoz's submission of an aBLA for PB006, a potential biosimilar of TYSABRI, violates 28 patents under the BPCIA
  •  Biogen also claims that patents covering the production of Abs are being violated. Tysabri is a humanized mAb targeting alpha-4 integrin & is indicated for MS and CD

Related Post: Insights+ Key Biosimilars Events of September 2022


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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