Tags : Samsung Bioepis

Insights+

Insights+ Key Biosimilars Events of September 2021

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

Insights+

PharmaShots’ Key Highlights of Third Quarter 2021

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

Weekly Snapshot

PharmaShots Weekly Snapshots (September 20 – 24, 2021)

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

Biosimilars Clinical Trials

Samsung Bioepis Presents Five-year Follow-up Results of Ontruzant (biosimilar, trastuzumab)

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

Insights+

Insights+ Key Biosimilars Events of August 2021

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

Biosimilars Regulatory

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

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

Insights+

Insights+ Key Biosimilars Events of July 2021

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