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STAT+: Pharmalittle: We’re reading about Novo targeting compounded obesity drugs, an Amgen ‘at risk’ launch, and more

STAT

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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Alexion Sues Samsung over Proposed Eculizumab Biosimilar

Big Molecule Watch

District Court for the District of Delaware, alleging infringement of 6 patents under the BPCIA based on Samsung’s submission of an aBLA for SB12, a proposed biosimilar to SOLIRIS (eculizumab). This is the first BPCIA litigation involving a eculizumab biosimilar. Alexion asserts that Samsung’s SB12 biosimilar product will infringe U.S.

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STAT+: Pharmalittle: WHO pandemic accord may force pharma to disclose prices; FDA OKs first therapy to delay type 1 diabetes

STAT

Diabetic patients will now have easier access to insulin after the FDA approved an Eli Lilly biosimilar as interchangeable with the biologic drug , Bloomberg News notes. Rezvoglar, The agency issued 62 warning letters and 23 import alerts related to drugs, excluding compound-related actions. As of 2019, about 1.9

Diabetes 242
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Natasha Daughtrey to Speak at ACI’s 14th Annual Summit on Biosimilars & Innovator Biologics

Big Molecule Watch

During this session, speakers will address the launch of Amgen’s AMJEVITA and the additional HUMIRA biosimilars expected to come to market in 2023. The speakers will draw on lessons learned from the HUMIRA biosimilars and engage in a predicative analysis of what this all means for other biosimilar launches.

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May 2023 Newsletter

Safe Biologics

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Global cell line development to surge in next decade

European Pharmaceutical Review

million in 2023, with a predicted compound annual growth rate (CAGR) of 4.1 The research also noted that these markets in Europe and North America will lead, due to “[higher] government funding in cell line development research and rising spending on biosimilar developments”. Total cell line product sales are expected to reach $3,124.4

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COVID-19 bites into Pfizer’s Q3, but biopharma revenues rise

pharmaphorum

Meanwhile, global biosimilar revenues jumped 80% to $424 million, driven by recent oncology biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) in global markets. The drug had been given FDA fast track designation.