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 September, Sandoz entered into a commercialization and license […]Read More
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]Read More
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]Read More
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis in a ratio (1:1) in 705 patients with wet AMD The results showed LS mean change in BCVA from baseline @52wks. (9.79 vs 10.41 letters) […]Read More
Shots: The P-III study evaluates the cardiac safety profiles & efficacy of Ontruzant vs reference trastuzumab in 367 patients with HER2 positive early or LA BC for 4yrs. after randomization Patients were randomized to receive 8 cycles of either Ontruzant or TRZ with concurrent neoadjuvant CT. After surgery, patients received 10 cycles of biosimilar trastuzumab […]Read More
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 […]Read More
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 August, Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) received EC’s […]Read More
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
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 Jul, Viatris & Biocon’s Semglee got the US […]Read More
Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe plaque psoriasis Additionally, patients either continue on Stelara or transition to SB17 @28wks. The IPs (SB17 or Stelara, q12w) will be administered @0, 4 and […]Read More
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