AVITA Medical Launches Cohealyx for Wound Healing in the US

Shots: AVITA Medical has launched Cohealyx, collagen-based dermal matrix in the US Cohealyx is currently being evaluated in the post-market Cohealyx I trial (enrolment ongoing) to further assess clinical outcomes, wound bed preparation for definitive closure, & patient recovery timelines Cohealyx, developed by AVITA & Regenity Biosciences, is designed to support cellular migration & revascularization, allowing…

ByRidhi RastogiApril 4, 2025

NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…

ByRidhi RastogiApril 2, 2025

NEWS

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Shots: Zealand Pharma & Roche will develop & market petrelintide & its products incl. petrelintide + CT-388 (Roche’s asset) in the US & EU for weight loss, with Roche obtaining exclusive marketing rights in the rest of the world Zealand will handle ~50% marketing in the US & EU with opt-in/out rights under specific…

ByRidhi RastogiMarch 12, 2025

NEWS

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Shots: Biocon Biologics has entered into strategic collaboration agreement with Civica to extend access & affordability of Insulin Aspart in the US As per the deal, Biocon will supply Insulin Aspart drug substance to Civica, which will manufacture prefilled pens & vials of insulin at its Petersburg, Virginia facility. Civica will commercialize it in the US…

ByRidhi RastogiMarch 7, 2025

NEWS

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

NEWS

Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US

Shots: Biocon Biologics has launched Yesintek (ustekinumab- kfce), a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial The approval was…

ByRidhi RastogiFebruary 24, 2025

NEWS

Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

Shots: Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr…

ByRidhi RastogiFebruary 24, 2025

NEWS

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots: The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

ByRidhi RastogiFebruary 20, 2025

NEWS

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Shots: Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha,…

ByRidhi RastogiFebruary 10, 2025

INSIGHTS+

New Drug Designations – October 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices. Significant trends this month…

BySaurabh ChaubeyNovember 26, 2024

AVITA Medical Launches Cohealyx for Wound Healing in the US

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US

Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

New Drug Designations – October 2024

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