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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product.

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Alvotech gets new FDA review for Humira biosimilar

BioPharma Drive: Drug Pricing

The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.

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Analyzing biosimilar market dynamics in different patient populations

Drug Patent Watch

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar

BioPharma Drive: Drug Pricing

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

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Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Marijuana would also remain subject to applicable provisions of the Food, Drug and Cosmetics Act.

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Valuation of Pharma Companies: 5 Key Considerations

Drug Patent Watch

Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Evaluate the number of products in development, their potential market size, and the competition. Regulatory Environment : Changes in regulatory policies can impact a company's valuation.

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection.

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