2025 Biosimilars Compounding 
FDA Law Blog: Biosimilars
FEBRUARY 2, 2025
By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.
Express Pharma
JANUARY 11, 2024
The sales growth of gout therapies across the seven major markets (7MM: the US, 5EU, and Japan) is set to increase at a compound annual growth rate (CAGR) of 8.8 Canakinumb, set for a 2030 launch, is a biosimilar to the established Ilaris therapy. per cent from $4.6 billion in 2022 to $10.8
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FDA Law Blog: Biosimilars
SEPTEMBER 11, 2024
FDA says that highly potent compounds – again, as defined in ICH M7(R2) – pose risks below that limit. The revisions due in 2025 include testing for NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5 We note that the other FDA guidance document on nitrosamines addresses NDSRIs.
Express Pharma
NOVEMBER 2, 2023
Though the entry of biosimilars will contract the market, significant growth is expected over the next 8-10 years, driven by the launch of new assets. Against this backdrop, the CD drug sales across the eight-major markets (8MM*) are set to increase at a compound annual growth rate (CAGR) of 4.7 per cent from $9.5
Express Pharma
JUNE 5, 2023
billion in 2031 across the 8MM, registering a compound annual growth rate (CAGR) of 1.9 Constellation Pharmaceuticals’ BET inhibitor pelabresib is also set to gain FDA approval in 2025, straight into the first-line setting in combination with Jakafi with the view to improve clinical responses from day 1 of therapy.
Express Pharma
OCTOBER 16, 2024
The CRO sector in India, growing at a compound annual growth rate (CAGR) of 10.75 Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally. per cent, is projected to reach $2.5 billion by 2030 (2). per cent, hitting $44.63
FDA Law Blog: Biosimilars
DECEMBER 3, 2023
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. Final Guidance at 2.
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