Big Molecule Watch

JANUARY 5, 2024

Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. A status conference took place today January 5, 2024 in relation to Regeneron’s emergency motion. Patent Nos. Patent Nos. Design Patent Nos.

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Packaging Biosimilars Documentation 62

FDA Law Blog: Biosimilars

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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Packaging 52

Express Pharma

JUNE 5, 2023

It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. Indian pharma is expected to touch the $65 billion mark by 2024.

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Packaging Vaccines Biosimilars 91

FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

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Packaging 102

PharmaShots

MARCH 1, 2023

In preclinical studies, HLX15 is highly similar to daratumumab Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US Date- February 01, 2023 Product: Amjevita The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases.

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Biosimilars Packaging Labelling 40

Pharmaceutical Technology

MAY 23, 2023

While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. Generic and biosimilar firms are likely to heavily utilise this provision, and earlier market entry may lead to faster price drops for branded drugs.

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Pharmaceutical Companies Pharmaceutical Companies Biosimilars Packaging 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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Labelling Packaging Documentation 59