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Key Biosimilars Events of November 2024
INSIGHTS+

Key Biosimilars Events of November 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        A major highlight was the EC’s approval of Sandoz’ Afqlir for treating…
December 3, 2024

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Intas & Coherus
NEWS

Intas Pharmaceuticals to Acquire Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta) 

   Shots:  Intas Pharmaceuticals, through its US specialty division Accord BioPharma, has entered into an agreement to acquire Coherus’ Udenyca business (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta, to enhance Accord’s biosimilar product portfolio. Deal is expected to conclude in Q1’25  Udenyca is indicated to reduce infection risk from febrile neutropenia in patients with non-myeloid malignancies,…
December 3, 2024

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Biocon Biologics
NEWS

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara) 

Shots:  The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab)  Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen  Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…
December 1, 2024

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BridgeBio
NEWS

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM 

Shots:    The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025  Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…
November 22, 2024

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AOP health
INSIGHTS+

AOP Health’s Rapiblyk (landiolol) Receives the US FDA’s Approval for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting 

Shots:    The US FDA has granted approval to Rapiblyk for treating severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter) in critical care setting  Approval was supported by 5 clinical trials assessing the safety & efficacy of Rapiblyk (9.3 to 74.6 mcg/kg/min) vs PBO in adults (n=317) with supraventricular tachycardia, showing 40-90% vs 0-11%…
November 22, 2024

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EMA Marketing Authorization of New Drugs in October 2024
INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2024

Shots:    The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis  PharmaShots has…
November 21, 2024

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Pfizer New
NEWS

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

  Shots:    The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway  Approval was based on pivotal P-III (BASIS) study of Hympavzi…
November 20, 2024

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Jazz Pharmaceuticals
INSIGHTS+

Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC) 

Shots:    The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based on P-IIb (HERIZON-BTC-01) study in patients (n=87) with HER2+, locally advanced unresectable or metastatic BTC across 2 arms, based on tumor IHC status  Efficacy in 62 HER2+ BTC patients (arm 1 of HERIZON-BTC-01) showed a 52% ORR & 14.9mos. mDoR. Continued approval depends…
November 20, 2024

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Disease of the Month – Gastroparesis
INSIGHTS+

Disease of the Month – Gastroparesis

Shots:  Gastroparesis is a chronic gastrointestinal disorder characterized by delayed gastric emptying, leading to symptoms such as nausea, vomiting, bloating, and early satiety. This condition significantly affects patients' quality of life, posing challenges for diagnosis and treatment.   Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the…
November 19, 2024

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NEWS

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab) 

Shots:  Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU  As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…
November 19, 2024

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