FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing?

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Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. for the years 2020 to 2022.

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Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

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Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine? and the E.C.

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Agency IQ

AUGUST 2, 2024

For example, the German medtech trade organization (BVMed) is hosting a webinar on September 9 to offer industry an overview of the upcoming launch of upcoming cybersecurity policy, European NIS-2 Directive ( EU 2022/2555 ) that aims to harmonize cybersecurity measures across the E.U

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