Remove Bioequivalency Remove Production Remove Regulation
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The drug industry continues to dare regulation

World of DTC Marketing

Reportedly, the cost of production for molnupiravir stands at about $17.74. A new study estimates the causal effects of coupons for branded drugs without bioequivalent generics using variation in coupon introductions over time and comparing differential responses across enrollees in commercial and Medicare Advantage plans.

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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

But this also reflects a wider trend within the broader market, which is moving towards complex biological and non-biological products, he adds. Supply chain issues also come into play, meaning that owning proprietary API production is an advantage, he says. The only way forward for generics producers.

Drugs 298
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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

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FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.