Insights+ Key Biosimilars Events of July 2022

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Insights+ Key Biosimilars Events of July 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 July, Polpharma Biologics reported EMA's acceptance of MAA for biosimilar Natalizumab, a proposed biosimilar to Tysabr for RRMS, Prestige Biopharma entered into a binding agreement with Intas to commercialize HD204 (biosimilar, bevacizumab) in multiple countries. Our team at PharmaShots has summarized 10 key events of the biosimilar space of July 2022

Xbrane Resubmit the BLA for Ranibizumab Biosimilar to Treat Serious Eye Disease

Published: July 04, 2022

Product: Ranibizumab Biosimilar

  • The US FDA offers a general advice letter with comments & recommendations for the resubmission of the BLA for the biosimilar candidate to Lucentis, based on the preliminary review. In 2022, the company is anticipated to resubmit the BLA
  • Xbrane withdrew the BLA for its biosimilar candidate to Lucentis at the end of May while the FDA stated that additional information was necessary to make the decision to accept the BLA and initiate a full review within 60 days post resubmission
  • The company will advance its biosimilar candidate towards approval in the US to offer patients with serious eye disease an affordable therapy option

Alvotech Initiates (ALVOEYE) Clinical Study of AVT06, a Proposed Biosimilar to Eylea for Eye Disorders

Published: July 08, 2022

Product: AVT06

  • The company initiates the (ALVOEYE) confirmatory study of AVT06, a biosimilar to Eylea in ~444 patients with eye disorders that can lead to vision loss or blindness incl. wet AMD, macular edema & DR. The 1EPs is the change in BVCA from baseline to 8wk.
  • The purpose of the study is to compare AVT06 & Eylea in terms of efficacy, safety & immunogenicity in adult patients with neovascular (wet) AMD
  • AVT02 (biosimilar, adalimumab) has been approved and launched in Canada & the EU and is slated to do the same in the US on July 1, 2023. The company also reported the positive results for AVT04, a proposed biosimilar to Stelara from confirmatory clinical, safety, efficacy & PK study

Sandoz Presents (REFLECT) Study Results of Riximyo (biosimilar, rituximab) Demonstrated Proven Effectivity for Large B-Cell Lymphoma at EHA 2022

Published: July 14, 2022

Product: Riximyo (biosimilar, rituximab)

  • The (REFLECT) study evaluates Riximyo vs Rituxan in patients with large B-cell lymphoma. The study was also the first postapproval trial of Riximyo + R-CHOP for CD-20+ DLBCL
  • The results showed confirmed comparable safety & effectiveness profiles b/w rituximab biosimilars & Rituxan, 110 patients achieved CR & 50 with PR, ORR (94.7%), PFS @1 & 2yrs. (84.9% & 78.5%), AEs in 84.6% of patients, SAEs in 63 patients
  • In a population-based analysis from Denmark, researchers used a lymphoma registry to compare the effectiveness of R-CHOP therapy using a rituximab biosimilar, 3yr. PFS for the originator & biosimilar (71.8% & 72.2%), the multivariable analysis revealed no differences in PFS or OS

Polpharma Biologics Report EMA's Acceptance of MAA for Biosimilar Natalizumab, a Proposed Biosimilar to Tysabr for Relapsing-Remitting Multiple Sclerosis

Published: July 15, 2022

Product: Biosimilar Natalizumab

  • The EMA has accepted the MAA for biosimilar natalizumab, a proposed biosimilar to Tysabr for highly active RRMS. Biosimilar natalizumab was developed by scientists at Polpharma Biologics
  • The MAA submission was based on analytical, preclinical & clinical data incl. P-III (Antelope) study to evaluate biosimilar natalizumab in patients with RRMS. The P-III (Antelope) & P- I trial met their 1EPs & shown that the effectiveness and safety of the biosimilar matched those of the reference drug
  • Under the 2019 agreement with Sandoz, Polpharma will be responsible for the manufacturing & supply of the product while Sandoz gets the rights to commercialize & distribute the proposed biosimilar

Pfizer and Celltrion Healthcare Report Real-World Study Results of CT-P13 (biosimilar, infliximab) for Inflammatory Bowel Disease

Published: July 16, 2022

Product: CT-P13 (biosimilar, infliximab)

  • The real-world study evaluates CT-P13 vs Remicade in 115 patients aged 44yrs. wit IBD incl. CD & UC at 24 sites in US & Canada for 12mos. For CD, 30.8% were biologic-naïve & 6.7% switched from reference infliximab & had a clinical response to treatment
  • The results demonstrated positive clinical & PROs. In UC & CD patients, 35.4% & 72.7% were in remission at baseline & 87.1% & 77.1% @12mos. In biologic-naïve patients with UC, the remission rate increased from 5.6% at baseline to 90.9% @12mos., and the avg. pMAYO decreased from 5.67 to 1.09 while remission rate & HBI scores did not change from baseline to 12mos. for CD. The results were published in Advances in Therapy
  • Patients switched from the reference infliximab, remission rates at baseline & 12mos. (75.4% & 83.0%), 9.6% reported IBD-related hospitalization

Hikma Entered into an Exclusive License Agreement with Celltrion for Yuflyma (biosimilar, adalimumab)

Published: July 18, 2022

Product: Yuflyma (biosimilar, adalimumab)

  • Hikma gets exclusive rights to commercialize Yuflyma, the first proposed high concentration, low-volume & citrate-free adalimumab biosimilar in MENA markets
  • The agreement will strengthen Hikma’s offering of biosimilar & biologic products with the addition of Yuflyma to its portfolio. Celltrion’s capabilities & well-established commercial presence continue to increase patient's access to vital medications that aid in their battle against challenging diseases
  • Hikma has launched three of Celltrion’s biosimilar products i.e., Truxima, Remsima & Herzuma. A fourth product, Remsima SC, an infliximab formulation is currently being developed & will be available soon

Celltrion Receives IND Approval for P-III Trial of CT-P47 (biosimilar, tocilizumab) to Treat Rheumatoid Arthritis in Poland

Published: July 19, 2022

Product: CT-P47 (biosimilar, tocilizumab)

  • URPL has approved the IND application of CT-P47 (biosimilar, tocilizumab) to initiate the P-III trial in 448 patients with RA in Poland
  • The company is planning to conduct comparative studies on the efficacy, safety, PK & immunogenicity of CT-P47 vs Acterma through the upcoming trials
  • Actemra is an interleukin formulation that decreases inflammation by blocking the interleukin-6 protein that is responsible for producing inflammation in the body & is used to treat RA, SJIA, polyarticular JIA, GCA & CRS. Additionally, the company is expected to receive the US FDA’s approval for its Humira biosimilar Yuflyma in 2022

Alvotech Reports the Initiation of Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia and Xgeva to Treat Bone Disease

Published: July 21, 2022

Product: AVT03

  • The company initiates a PK study to evaluate the PK, safety, and tolerability of AVT03 (denosumab) vs Prolia and Xgeva in healthy adult male patients with bone disease
  • Prolia is indicated for the treatment of osteoporosis in postmenopausal and to treat bone loss in adult men and women who are at increased risk of fracture. Xgeva is indicated to prevent skeletal fractures in patients with cancer incl. bone & for giant cell tumors in bone
  • The capabilities of Alvotech's biosimilars platform are demonstrated by the quick progress in the development of the product portfolio. In the EU and Canada, the company has launched AVT02 (adalimumab), a biosimilar to Humira

Sandoz Reports the US FDA and EMA's Acceptance of BLA & MAA for Natalizumab, a Proposed Biosimilar to Tysabri to Treat Multiple Sclerosis

Published: July 25, 2022

Product: Natalizumab

  • The US FDA has accepted the BLA for proposed biosimilar natalizumab that comprises all indications covered by reference natalizumab for MS incl. CIS, RRMS, active secondary progressive disease & CD. The therapy was being developed by Polpharma Biologics
  • The EMA also accepted the MAA for the proposed biosimilar natalizumab in RRMS.  The submission was based on the comprehensive data package incl. P-I & III (Antelope) study met their 1EPs & showed that the biosimilar was equivalent to the reference natalizumab in terms of efficacy, safety & immunogenicity
  • If approved, the biosimilar can increase access & deliver savings for healthcare systems. Under the 2019 agreement with Polpharma, Sandoz has the rights to commercialize the biosimilar in all markets

Prestige Biopharma Entered into a Binding Agreement with Intas to Commercialize HD204 (biosimilar, bevacizumab) in Multiple Countries

Published: July 26, 2022

Product: HD204 (biosimilar, bevacizumab)

  • Intas & its affiliate Accord will get exclusive rights for the commercialization of bevacizumab biosimilar in the US, EU, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan & Tajikistan. Prestige will lead the development & distribution 
  • The collaboration aims to broaden market reach in the EU & Canada using Accord's robust global footprint & in-depth commercial expertise
  • Bevacizumab is used in combination with other therapies for multiple cancer incl. metastatic colorectal cancer, NSCLC, kidney cancer & others. HD204 is being evaluated in the P-III (SAMSON-II) trial with expected plans for filing applications with regulatory authorities in the US & EU in 2023

Related Post: Insights+ Key Biosimilars Events of June 2022

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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