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Biosimilars

Prestige Biopharma and Pharmapark Sign an Exclusive License and Supply Agreement to Commercialize HD204 (biosimilar, bevacizumab) in Russia

Tuba Khan April 16, 2021
Prestige Biopharma and Pharmapark Sign an Exclusive License and Supply Agreement to Commercialize HD204 (biosimilar, bevacizumab) in Russia

Shots: Pharmapark to get exclusive rights to commercialize HD204 and is responsible for local registration, sales, and marketing of the biosimilar in Russia in collaboration with Russian import substitution strategy Prestige BioPharma will be responsible for commercial supply the product out of its manufacturing facilities in Osong, Korea Prestige’s (HD204) is currently being evaluated in […]

PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab
Biosimilars

PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop

Tuba Khan April 9, 2021

Shots: The agreement facilitates PlantForm’s collaborations in Brazil to provide affordable, effective cancer drugs to millions of Brazilians The 3yrs. research and development collaboration will culminate in protocols for P-I and P-III clinical trials. The companies will take biosimilar pembrolizumab to world markets, following the completion of clinical trials in Brazil Pembrolizumab is a biosimilar […]Read More

Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis
Biosimilars

Biogen Signs a License and Commercialization Agreement with Bio-Thera for

Tuba Khan April 9, 2021

Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]Read More

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

Samsung Bioepis Expand its Footprints with the Launch of Hadlima

Tuba Khan March 30, 2021

Shots: 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 […]Read More

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

EirGenix Report Results of EG12014 (biosimilar, trastuzumab) in P-III Trial

Tuba Khan March 25, 2021

Shots: 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 regards to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a […]Read More

mAbxience Collaborates with ABEC to Expand Biosimilar and CDMO Manufacturing Capacity
Biosimilars

mAbxience Collaborates with ABEC to Expand Biosimilar and CDMO Manufacturing

Tuba Khan March 23, 2021

Shots: 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 […]Read More

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

Waters Launches Peptide Multi-Attribute Method for BioAccord System to Develop

Tuba Khan March 18, 2021

Shots: 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 […]Read More

WuXi Biologics to Acquire Pfizer’s Biologics Manufacturing Facilities in China
Biosimilars M&A

WuXi Biologics to Acquire Pfizer’s Biologics Manufacturing Facilities in China

Tuba Khan March 18, 2021

Shots: 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 […]Read More

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