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Category : Biosimilars

Biosimilars Clinical Trials

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Tuba Khan September 10, 2021
Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and […]

Sandoz Enters into a Commercialization and License Agreement with Bio-Thera to Commercialize BAT1706, a Proposed Biosimilar Avastin (bevacizumab)
Biosimilars

Sandoz Enters into a Commercialization and License Agreement with Bio-Thera

Tuba Khan September 9, 2021

Shots: Bio-Thera to receive an up front, milestones along with royalties on product sales & will be responsible for the development, manufacturing, supply of BAT1706 Sandoz to get rights for the commercialization of the therapy upon approval in the US, EU, Canada, and other countries. Bio-Thera’s BAT1706 has completed extensive biosimilar studies, including a global […]Read More

Hetero’s Tocira (biosimilar, tocilizumab) Receives the DCGI’s EUA for the Treatment of COVID-19 in Hospitalized Adults
Biosimilars

Hetero’s Tocira (biosimilar, tocilizumab) Receives the DCGI’s EUA for the

Tuba Khan September 7, 2021

Shots: DCGI has granted a EUA for tocilizumab in India for the treatment of COVID-19 in hospitalized adults who receives systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO Hetero’s Tocira will be marketed by Hetero Healthcare in India & manufactured by Hetero Biologics Tocilizumab (400mg/20ml) is the biosimilar referencing Roche’s […]Read More

Bio-Thera and Hikma Sign an Exclusive Commercialization and License Agreement for BAT2206 (biosimilar, ustekinumab) in the US
Biosimilars

Bio-Thera and Hikma Sign an Exclusive Commercialization and License Agreement

Tuba Khan August 30, 2021

Shots: Bio-Thera to receive $20M up front and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of BAT2206 Hikma get exclusive rights to commercialize the biosimilar in the US and received first-right-to-negotiate to add Europe (excluding CIS countries) BAT2206 is a mAb, that is a proposed biosimilar […]Read More

Cipla Collaborates with Kemwell to Form Joint Venture to Develop and Commercialize Biosimilars
Biosimilars

Cipla Collaborates with Kemwell to Form Joint Venture to Develop

Tuba Khan August 25, 2021

Shots: The companies collaborated to form JV to develop, manufacture, and commercialize biosimilars for a global market The collaboration will utilize Cipla and Kemwell’s strengths for product development, clinical development, regulatory filings, manufacturing, and commercialization of biopharma products Cipla’s respiratory expertise & Kemwell’s biologics will combine to accelerate the products in the market Click here […]Read More

Nora Signs an Exclusive Agreement Biopharmaceutical Partner to Launch a Biosimilar in Canada
Biosimilars

Nora Signs an Exclusive Agreement Biopharmaceutical Partner to Launch a

Tuba Khan August 24, 2021

Shots: Nora collaborates with a biopharmaceutical partner to obtain the commercial rights for a biosimilar drug The collaboration will support both private insurers and public formularies by reducing the costs of biosimilars & provide accessibility to patients for high quality affordable pharmaceutical products Nora Pharma’s activities coordinate with the biosimilars transition policy adopted by several […]Read More

Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) Receives EC’s Approval for the Treatment of Ophthalmic in EU
Biosimilars Regulatory

Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) Receives EC’s Approval for the

Tuba Khan August 23, 2021

Shots: The EC has approved Byooviz (biosimilar, ranibizumab) in the EU for the treatment of Ophthalmic disease Lucentis is used to treat ophthalmic disease & macular degeneration. Byooviz marks the 1st biosimilar referencing Lucentis to be commercialized in the EU Samsung Bioepis & Biogen also plans to commercialize an aflibercept biosimilar SB15 which is currently […]Read More

Sandoz Reports Results of Omnitrope (biosimilar, somatropin) in PATRO Children Study for the Treatment of Turner Syndrome
Biosimilars

Sandoz Reports Results of Omnitrope (biosimilar, somatropin) in PATRO Children

Tuba Khan August 23, 2021

Shots: The PATRO Children, post marketing surveillance study evaluates biosimilar rhGH (Omnitrope) vs reference rhGH (Genotropin) in 348 children with TS at 130 centers across EU. In this study, 81.6% were rhGH naïve, and 90.2% were prepubertal The results demonstrated that the therapy was safe & effective in real-life clinical practice, was generally well tolerated […]Read More

Enzene Receives Marketing Authorization for Romiplostim (biosimilar) in India
Biosimilars

Enzene Receives Marketing Authorization for Romiplostim (biosimilar) in India

Tuba Khan August 20, 2021

Shots: DCGI has granted the marketing authorization to Enzene’s Romiplostim biosimilar for the treatment of chronic ITP in adults The company provides all the three dosage strengths of the product (125mcg, 250mcg, and 500mcg) Romiplostim is an Fc-peptide fusion protein that increases platelet production through activation of the thrombopoietin receptor. The company’s first biosimilar Teriparatide […]Read More

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