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

Biosimilars 86

Biosimilars Compounding 86

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.

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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

Biosimilars 88

Biosimilars Compounding Pharmaceutical Companies Pharmaceutical Companies 88

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.

Drug Development 84

Drug Development Biosimilars Compounding 84

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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Labelling Drug Pricing Compounding Payment Processing 104

Express Pharma

JULY 10, 2024

Brimming with potential As per an Invest India report of 2023, the Indian Bioeconomy, valued at $137 billion in 2023, is targeted to reach $150 billion by 2025 and $300 billion by 2030. IBER Report 2023 divulges, “The biopharma vaccines (non-COVID alone) market makes a significant daily contribution of approximately $38 million. billion.”

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Vaccines Drug Development Process Improvement Biosimilars 80

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

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Biosimilars Compounding 80