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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 from 2020 to 2025[1].

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Bio-Techne Joins Forces with USP to Speed Up Development of mAbs and Gene Therapies

The Pharma Data

As demand for these therapies continues to surge, particularly with the emergence of biosimilars, the necessity for strict quality controls during development and manufacturing becomes paramount. These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success.

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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

Notably, many of the issues regarding drugs are typically considered the practice of medicine, which FDA does not regulate. Similarly, FDA can use post-marketing requirements (PMRs). That leaves us to speculate what the implications of this Assessment will be.

Drugs 59
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Regulatory considerations for biosimilar clinical efficacy trials

Drug Patent Watch

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Valuation of Pharma Companies: 5 Key Considerations

Drug Patent Watch

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

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Pharma Contract Sales Outlook 2025–2030: Multilingual Teams Drive Global Expansion

The Pharma Data

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3 In the U.S.,