• 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, Samsung initiated patient enrollment in the P-III MYLIGHT study for nAMD while Zydus launches Ujvira. Meiji reported the results of the P-I study of DMB-3115. Our team at PharmaShots has summarized 14 key events of the biosimilar space of May 2021

Samsung Bioepis Presented Results of SB11 (proposed biosimilar ranibizumab) at ARVO 2021

Published: May 03, 2021

Product: SB11 (proposed biosimilar ranibizumab)

• The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
• The analytical assessment demonstrated that structural, physicochemical characterization i.e. amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to Lucentis
• The SB11 is also functionally similar to Lucentis based on a set of bioassays and binding assays covering a broad range of VEGF-related functional activities. SB11 is under review by the US FDA and EMA

Sandoz Initiated Patient Enrolment of Proposed Biosimilar Aflibercept in P-III MYLIGHT Study for Neovascular Age-Related Macular Degeneration

Published: May 04, 2021

Product: Proposed Biosimilar Aflibercept

• The company starts enrolling patients in the P-III MYLIGHT study to evaluate the safety and efficacy of biosimilar aflibercept vs Eylea in patients with nAMD for 48wks. The study is expected to enroll 460 patients across 20 countries
• The study is a part of a biosimilar development program that includes analytical, pre/ clinical data. The study focuses to confirm the efficacy & safety of biosimilar aflibercept to the Eylea
• The company has eight marketed biosimilar medicines globally and 15+ molecules in the pipeline and focuses to expand the access to affordable biologics

Amgen Launched Amgevita (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases in Canada

Published: May 05, 2021

Product: Amgevita (biosimilar, adalimumab)

• The company reports the availability of Amgevita, referencing Humira to treat 11 chronic inflammatory conditions in Canada
• Amgevita is available as a prefilled syringe and a prefilled pen (SureClick autoinjector) with a broad range of pack sizes to support dosing for each indication and available in a citrate-free formulation. Amgevita is reimbursed on the public drug for all indications of Humira in British Columbia, Alberta, Ontario, Quebec, New Brunswick and Newfoundland
• The approval was based on the clinical study that supports bio-similarity with the Humira and showed no clinical differences from the reference product

Alvotech  to End the AbbVie's Wrong Monopoly on Humira and Develops New Biosimilar for Chronic Pain

Published: May 11, 2021

Product: AVT02

• Alvotech has filed a federal lawsuit to end the monopoly on AbbVie's Humira for taking several improper steps to inflate its patent portfolio includes multiple patents on the same invention and obtain patents through inequitable conduct
• Alvotech develops AVT02 as a biosimilar of Humira for chronic pain with equal in strength to Humira's latest formulation and develops AVT02 as an interchangeable product and expects the results from its ongoing interchangeability study in Q2'21
• The biosimilars are available across EU and in Japan, Canada, and Australia and expect to save US taxpayers and the overall healthcare system of $8-10B annually

Viatris Expected its First Interchangeable Designation for Insulin Products

Published: May 14, 2021

Product: Insulin Glargine and Insulin Aspart

• Viatris reported that its insulin glargine and insulin aspart products are both on track to be approved by the FDA as interchangeable by July 2021
• The biosimilars are the proposed biosimilars of Sanofi's Lantus and Novo Nordisk's Novolog/Novorapid products respectively
• If approved, Viatris's insulin products would be the first biosimilars to receive the US FDA's interchangeable designations

Xbrane Initiated New Biosimilar Development Program Annually

Published: May 16, 2021

Product: Biosimilar

• Xbrane to initiate a new biosimilar development program annually and planning to generate positive operating cash flow monthly on the back of expected Xlucane net-income by late 2023/early 2024
• Xlucane (biosimilar, ranibizumab) referencing Lucentis is currently in the P-III trial with expected results in mid-2021, regulatory submissions are underway in the EU in Q3 & the US in Q4'21. If approved, Xlucane will be launched across the EU and the US
• The company has set the foundation for growth through establishing a new biotech lab at Campus Solna with a team of 50 professionals to take biosimilars from cell-line to approval and strengthen its high yield/low-cost platform technology

Sandoz Launched Inclunox and Inclunox HP (biosimilar, enoxaparin sodium solution) in Canada

Published: May 17, 2021

Product: Inclunox and Inclunox HP (biosimilar, enoxaparin sodium solution)

• The company expands its portfolio with the marketing of the 6th biosimilars in Canada. Inclunox and Inclunox HP (enoxaparin sodium solution for injection) is indicated for use in 6 indications of the reference Lovenox and Lovenox HP in oncology, immunology, and endocrinology
• Sandoz Canada has completed the pCPA negotiations for Inclunox and Inclunox HP, which is the first step in securing public reimbursement. The INESSS recommends that new biosimilar be listed on the List of Medications
• Inclunox (IV or SC) is an anticoagulant biosimilar and is available in multiple prefilled syringes. Health Canada has authorized Lovenox and Lovenox HP on Nov 05, 2020 for marketing in Canada

The US Supreme Court Denied Sandoz's Petition for Erelzi (biosimilar, etanercept)

Published: May 17, 2021

Product: Biosimilar

• The US Supreme Court has denied Sandoz petition to review Federal Circuit's July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for the reference product, Enbrel (etanercept)
• The company was unable to launch the product in the US due to patent litigation. The affordable biosimilar will not be available in the US till 2029 to treat autoimmune and inflammatory diseases
• Erelzi has been approved in the US for more than 4yrs. since Aug'2016

Sandoz Canada Congratulated the Quebec Government on Implementing a Shift Towards Biosimilars

Published: May 18, 2021

Product: Biosimilar

• Quebec will follow a similar approach to policies introduced in British Columbia, Alberta and recently in New Brunswick to transition patients who use a reference biologic to a biosimilar. This will contribute to annual savings that can be reinvested in healthcare and innovative new drugs
• The transition will take place under the supervision of the attending physicians & patients will continue receiving safe & effective treatment
• Sandoz Canada is committed to supporting patients, their HCPs, and the Quebec government throughout the transition period with quality biosimilar medicines, medical teams, physician, and pharmacist advocacy teams, as well as with patient support programs

Quebec Reported the Intention on Implementing Shift Towards Biosimilars

Published: May 19, 2021

Product: Biosimilar

• Quebec government has stated province intention to shift towards biosimilars and follows the transition policies implemented by British Columbia, Alberta & New Brunswick
• The expanded use of biosimilars is expected to generate annual savings of $100M for the public drug insurance plan and its insured parties that can be reinvested in healthcare and innovative new drugs
• Under the policy, the transition from reference biologic to a biosimilar will take place under the supervision of treated physicians by April 12, 2022

Meiji Reported Results of P-I Study of DMB-3115 (proposed ustekinumab biosimilar) and Initiate P-III Study for Plaque Psoriasis

Published: May 21, 2021

Product: DMB-3115 (proposed ustekinumab biosimilar)

• The P-I study involves assessing pharmacokinetics, safety, and tolerability of DMB-3115 with its reference products (US- and EU-marketed products) in 296 healthy volunteers at a single site in the EU
• DMB-3115 showed bioequivalence to the reference and was well tolerated. The reported AEs corresponded with the known safety profile of ustekinumab with no new unexpected AEs
• The company has initiated P-III multi-regional clinical trials assessing DMB-3115 and reference products (45mg or 90mg, SC, respectively) in patients with plaque psoriasis, with the target number of patients being 590 and has been initiated in the EU & the US

Zydus Cadila Launched Ujvira (biosimilar, trastuzumab emtansine) for Early and Advanced HER2 Positive Breast Cancer

Published: May 24, 2021

Product: Ujvira (biosimilar, trastuzumab emtansine)

• Ujvira is made by combining Trastuzumab and a cytotoxic compound Emtansine (DM1) utilizing a stable linker by Antibody Drug Conjugation and is supported by drug development program
• Ujvira be available in 2 strengths (100 & 60mg) and the therapy will be priced at nearly 80% less than the currently available option in the market (Rs. 1,59,225 for 100 mg vial)
• Patients already treated with Trastuzumab may still suffer with the disease and would require this therapy as the next step. The expensiveness is a barrier to availing this therapy and Ujvira will resolve this need

BioFactura Initiated P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand

Published: May 26, 2021

Product: BFI-751 (biosimilar, ustekinumab)

• The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia and New Zealand
• The primary objective of the study is to compare PK of BFI-751 to US & EU-Stelara following a single dose under the skin. The study will also assess the safety & tolerability of BFI-751 in 210 healthy volunteers and their immune response
• The first three sentinel groups have been dosed with no AEs reported to date. The safety review committee has recommended the study progress with the opening of all three clinical sites which are now accepting new volunteers for the trial

Prime Therapeutics Launched MedDrive for Greater Biosimilar Drug Adoption

Published: May 26, 2021

Product: Biosimilar

• Prime Therapeutics launches MedDrive in multiple phases and provide a solution to help Blue Plan clients for greater biosimilar adoption and drug cost-saving strategies
• Prime helps the Blue Plan clients through a 100% transparent, unbiased PBM model that serves nearly 33M members across 23 Blue Plans
• Prime and Blue Cross plans to improve the use of biosimilars and other lower cost for effective treatment and to deliver improved affordability without compromising patient outcomes

Related Post: Insights+ Key Biosimilars Events of April 2021