Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications

Shots: The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US The approval was based…

ByDipanshu DixitMay 20, 2024

NEWS

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer

Shots: The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL3-targeting bispecific T-cell engager) for treating extensive-stage small cell lung cancer (ES-SCLC) adults whose disease progressed post Pt-based CT. Full approval depends upon confirmatory trials The approval was based on the P-II (DeLLphi-301) study assessing Imdelltra (10mg, Q2W) in SCLC patients (n=99) failing on…

ByDipanshu DixitMay 16, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2024 The US FDA approved a total of 12 new drugs including 11 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was X4 Pharmaceuticals’ Xolremdi for…

ByDipanshu DixitMay 14, 2024

NEWS

Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US

Shots: Xbrane & STADA have signed an exclusive license agreement with Valorum Biologics to commercialize Xlucane, biosimilar of ranibizumab, across the US As per the agreement, both companies will complete the regulatory approval process; Xbrane to handle commercial manufacturing & supply. Post approval, Valorum will take care of sales, marketing & other commercial activities of…

ByDipanshu DixitMay 10, 2024

NEWS

Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection

Shots: The US FDA has approved Azurity Pharmaceuticals’ Myhibbin oral suspension with its commercial availability anticipated in Q2’24 Myhibbin in addition to other immunosuppressants is intended for preventing organ rejection in adults & pediatric patients (age: ≥3mos.) of allogeneic kidney, heart, or liver transplant Mycophenolate mofetil, an antimetabolite immunosuppressant, works on the immune system of…

ByDipanshu DixitMay 6, 2024

NEWS

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Approval

Shots: The US FDA has approved Selarsdi (ustekinumab-aekn) injection (SC) for adults & pediatric patients (≥6yrs.) with moderate to severe plaque Pso & active PsA. Teva will commercialize it in the US as per an agreement b/w Teva & Alvotech The approval was based on 2 studies incl. AVT04-GL-301 trial assessing the efficacy, safety &…

ByDipanshu DixitMay 5, 2024

NEWS

Lupin and Sandoz Launch Rymti (Biosimilar, Enbrel) in Canada to Treat Plaque Psoriasis

Shots: Followed by HC’s approval in Aug 2022, Lupin with its partner Sandoz launched Rymti (biosimilar, Enbrel) in Canada The study showed that Rymti has equivalent safety and efficacy to Enbrel. It is a solution for injection in the form of a pre-filled pen & pre-filled syringe Rymti is intended to treat children and…

ByDipanshu DixitMay 3, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of April 2024

Shots: 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 patients   During April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva.…

ByDipanshu DixitMay 2, 2024

NEWS

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

Shots: Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023 The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…

ByDipanshu DixitMay 1, 2024

NEWS

Aquestive Therapeutics’ Libervan Buccal Film Receives the US FDA’s Approval to Treat Seizure Activity

Shots: Aquestive’s Libervant buccal film (oral, 5mg, 7.5mg, 10mg, 12.5mg & 15mg) received the US FDA’s approval as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures), distinct from the usual pattern in epilepsy patients (2-5yrs.) The company further provided an update on Anaphylm (epinephrine) sublingual film,…

ByDipanshu DixitApril 29, 2024

Dipanshu Dixit

Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer

Insights+: The US FDA New Drug Approvals in April 2024

Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US

Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Approval

Lupin and Sandoz Launch Rymti (Biosimilar, Enbrel) in Canada to Treat Plaque Psoriasis

Insights+ Key Biosimilars Events of April 2024

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

Aquestive Therapeutics’ Libervan Buccal Film Receives the US FDA’s Approval to Treat Seizure Activity

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