• 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 March, Samsung Bioepis Initiated P-I Study of SB17 Proposed Biosimilar to Stelara (ustekinumab)where as Alteogen Reported Completion of P-I Study of ALT-L9 (biosimilar, aflibercept) in Korea. Our team at PharmaShots has summarized 15 key events of the biosimilar space of March 2021

Formycon and Bioeq Confirmed BLA Submission Strategy and Timeline for FYB201 (biosimilar, ranibizumab)

Published: Mar 01, 2021

Product: Biosimilar

• The companies confirm the planned timeline for resubmission of the BLA for FYB201 following a successful pre-BLA interaction with the US FDA
• In Nov'2020, the initial submission strategy of FYB201 (biosimilar referencing Lucentis) has been adjusted as part of a simplification of the approval procedure
•  The BLA-submission is expected to be filed with the US FDA in H1'21 while the submission to the EMA is expected to follow-up. Additionally, the companies are seeking approval for FYB201 in Canada, Australia, the UK and Switzerland

Samsung Bioepis Initiated P-I Study of SB17 Proposed Biosimilar to Stelara (ustekinumab)

Published: Mar 02, 2021

Product: Stelara (ustekinumab)

• The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a ratio (1:1:1) aged 18-55yrs. All IPs will be administered subcutaneously in the abdomen
• Samsung Bioepis has four biosimilar candidates SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III and SB17 (ustekinumab) in P-I clinical trial
• With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

Cipla Expanded its Partnership with Alvotech to Commercialize Biosimilars in Australia and New Zealand

Published: Mar 02, 2021

Product: Biosimilar

• The companies collaborated for marketing and distribution of four biosimilars in Australia and New Zealand
• Cipla Gulf will be responsible for commercialization of patented biosimilars of the biologic medicine brands, covering therapeutic categories across immunology, osteoporosis, oncology as well as ophthalmology
• Alvotech will manufacture and develop the products and will be distributed by Cipla Gulf through Australia and New Zealand distribution networks. Earlier, in Jun 2019, Cipla collaborated with Alvotech for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets

Biocon Biologics and Viatris Received CHMP's Positive Opinion for Abevmy (biosimilar, bevacizumab)

Published: Mar 03, 2021

Product: Abevmy (biosimilar, bevacizumab)

• The CHMP has adopted a positive opinion recommending the marketing authorization of Abevmy (inj. bevacizumab 100 & 400mg), which is co-developed by Biocon and Viatris
• The companies expect the EC's decision in May'2021, which will grant the approval in 27 EU member countries and EEA member states of Norway, Iceland and Liechtenstein. For the UK, MHRA's reliance procedure will be followed, and the UK marketing authorization can be expected shortly after the EC decision
• Abevmy is a biosimilar referencing Roche's Avastin and is a humanized mAb that selectively binds to human VEGF and neutralizes its biological activity. Abevmy is available for all indications of its reference products

Alteogen Reported Completion of P-I Study of ALT-L9 (biosimilar, aflibercept) in Korea

Published: Mar 09, 2021

Product: ALT-L9 (biosimilar, aflibercept)

• The company has completed a P-I trial that assessed ALT-L9 vs Eylea in 28 patients in a ratio (1:1) with neovascular (wet) AMD. The trial was conducted at 4 major hospitals in Korea
• The safety & efficacy of ALT-L9 were similar to Eylea and the results showed similar improvement effects in BCVA and CST. The P-I results will support the design of the P-III study and provide a path to a shorter P-III trial
• Alteogen strengthens the competitiveness through global formulation and patents registration in the US, EU and Japan and filing of a process patent for PCT application

Lannett Received the US FDA's Feedback for Development of Biosimilar Insulin Glargine

Published: Mar 11, 2021

Product: Biosimilar Insulin Glargine

• The US FDA provide feedback on the pivotal trial protocol and statistical analysis plan (SAP) for the development program of biosimilar insulin glargine candidate, which the company plan to launch in 2023
• The US FDA has requested Lannett to submit a protocol for the pivotal trial for review before IND submission. Lannett plans to initiate a pivotal trial for the development of biosimilar insulin glargine candidate in early 2022 and intends to file BLA in 2022
• The study indicates that the Lannett/HEC insulin glargine product was similar to the US approved Lantus (the reference biologic) by meeting all PK and PD safety endpoints in the study

Henlius Reported First Patient Dosing in P-II/III Study of HLX10 + HLX04 (biosimilar, bevacizumab) for 1L mCRC

Published: Mar 11, 2021

Product: HLX04 (biosimilar, bevacizumab)

• The first patient has been dosed in a P-II/III clinical trial of HLX10 in combination with HLX04 (bevacizumab) and CT for 1L treatment of mCRC
• The combination regimen aims to benefit patients with I-O mAbs combination therapy as early as possible, further delaying the disease progression and improving the survival status of patients with mCRC
• HLX10 is a recombinant humanized anti- PD-1 mAb injection. HLX10 in combination with HLX04 is the first domestic mAbs combination therapy approved for clinical trials in China, which has been carried out late-stage clinical studies in NSCLC and HCC previously

Samsung Bioepis and Yuhan Collaborated for the Commercialization of Adalloce (biosimilar, adalimumab) in Korea

Published: Mar 15, 2021

Product: Adalloce (biosimilar, adalimumab)

• Samsung Bioepis enter into a marketing collaboration with Yuhan Corporation for the domestic sale of Adalloce in Korea to treat RA, AS, and CD
• Additionally, Samsung Bioepis is conducting domestic sales of Etoloce (biosimilar, enbrel) and Remaloce (biosimilar, Remicade), which have been previously released, through Yuhan Corporation
• Based on the contract, the cooperation between the two companies can be further strengthened

NCCN Collaborated with Pfizer for New Biosimilars Research Projects in Oncology

Published: Mar 17, 2021

Product: Biosimilar

• NCCN collaborates with Pfizer to select ten projects to receive funding and strengthen innovations to improve the lives of people with cancer and adopt biosimilars in oncology
• NCCN committed to exploring new avenues with the availability of affordable, effective treatment options in oncology
• NCCN ORP will support preclinical, translational, clinical research, and quality improvement projects in oncology

WuXi Biologics Acquired Pfizer's Biologics Manufacturing Facilities in China

Published: Mar 18, 2021

Product: Biosimilar

• WuXi Biologics signs an equity agreement with Pfizer to acquire its state-of-the-art biologics manufacturing facilities along with its labor force in Hangzhou, China. The transaction is expected to close in H1'21
• The agreement will boost WuXi Biologics commercial DS & DP capabilities to address surging manufacturing demands
• The state-of-the-art 50,000 m2 facilities include DS capacities equipped with 2x2000L single-use bioreactors expandable to 4x2000L (MFG20) and DP capacities of vial filling (DP9) and pre-filled syringe (DP10). Wuxi will commence the production following the deal closure

Waters Launched Peptide Multi-Attribute Method for BioAccord System to Develop and Commercialize Biosimilars

Published: Mar 18, 2021

Product: Biosimilar

• The new peptide MAM workflow for the BioAccord LC-MS system that helps to monitor critical quality attributes of protein-based drugs that can affect the safety & efficacy of innovator drugs and biosimilars
• By integrating BioAccord system on the waters_connect platform, scientists have a sensitive multiplexed method to accurately assess the attributes of protein-based drugs that enable rapid decision-making for product development, manufacturing, and release. The system also monitors product variants, degradation and impurities, and process stability
• The BioAccord system combines the ACQUITY UPLC I-Class and ACQUITY RDa mass detector featuring SmartMS enabled usability features

Henlius HLX04-O (biosimilar, bevacizumab) Received the US FDA's IND Approval for wAMD

Published: Mar 19, 2021

Product: HLX04-O (biosimilar, bevacizumab)

• The US FDA has approved the IND application of HLX04-O for the treatment of wAMD
• The P-III clinical study of HLX04-O will be conducted to further evaluate the efficacy and safety of HLX04-O in patients with wAMD in the near future. The study will enroll 388 patients from Chinese mainand, Australia, Russian Federation, Singapore, Spain and Poland
• Henlius and Essex will speed up the global clinical trials of HLX04-O and apply approval in different countries and regions across the globe based on the research results

mAbxience Collaborated with ABEC to Expand Biosimilar and CDMO Manufacturing Capacity

Published: Mar 23, 2021

Product: Biosimilar

• mAbxience will equip their state-of-the-art cGMP facility in Spain with an ABEC 4,000L CSR Bioreactor
• The system will be commissioned mid-2021 and will increase biosimilar and CDMO manufacturing capacity at the León site
• The 4,000L volume & performance comparable to stainless steel systems will enable mAbxience to improve flexibility, productivity and efficiency. The CSR bioreactor design also allows for seamless scale-up and transfer of cell culture processes, thereby reducing time to market for mAbxience's products

EirGenix Reported Results of EG12014 (biosimilar, trastuzumab) in P-III Trial for HER2-Positive Breast Cancer

Published: Mar 25, 2021

Product: EG12014 (biosimilar, trastuzumab)

• The P-III trial involves assessing the safety, immunogenicity and PK of EG12014 (trastuzumab, biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer
• The trial met its 1EPs showed equivalent efficacy to Herceptin in regard to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a comparable safety profile in the pre-operative treatment setting
• The company is preparing to submit BLA to the US FDA, MAA to EMA and NDA to TFDA

Samsung Bioepis Expanded its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

Published: Mar 30, 2021

Product: Hadlima (biosimilar, adalimumab)

• Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases
• With the launch in Australia, Samsung Bioepis adalimumab is now available in three markets: Europe, Canada, and Australia
• Hadlima is Samsung Bioepis third anti-TNF biosimilar launched in Australia, following the launch of Brenzys (etanercept) and Renflexis (infliximab). Hadlima will be available on the PBS from Apr 01, 2021

Image Source: The Conversation

Related Post: Insights+ Key Biosimilars Events of February 2021