FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement. What led to NPA’s lawsuit?

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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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The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd. On March 9, 2022, the U.S. Teva Pharmaceutical Industries Ltd. Prescribers should be aware of the possibility of long-term ophthalmologic effects. About Teva.

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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

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. The Agenda is typically updated twice per year, and it was last released in early January 2023.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

is expressly authorized to rely upon the regulatory review activities by Pfizer Ireland Pharmaceuticals (Pfizer), the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. exclusively licensed U.S. and OPKO Ireland Ltd. and OPKO Ireland Ltd. through OPKO Ireland Ltd.,

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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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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). As a reminder, the U.S. government fiscal year runs from October 1 – September 30.

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Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 2022 [cited 2023Feb24].

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Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 7:50 PM EDT | UPDATED JUN 26, 2023 12:41 PM EDT Note: This calendar also include some activities scheduled to take the last week of June, after this piece is published. Was supposed to be finalized as of June 24, 2022. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority B List.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., had Part D expenditures on or before August 16, 2022).

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. In April 2021, Pfizer and BioNTech entered into an agreement with Israel to supply millions of doses in 2022, with an option to purchase millions of additional doses.

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Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

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