FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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JANUARY 24, 2021

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The FTD is designed to make important new drugs accessible to patients faster.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

DECEMBER 29, 2020

” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. Protalix has licensed to Pfizer Inc. About Fabry Disease.

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The Pharma Data

JANUARY 15, 2021

About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.

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The Pharma Data

AUGUST 3, 2021

The Company has initiated discussions with regulators on the Phase 3 study design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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The Pharma Data

AUGUST 29, 2020

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. Heart disease and stroke Statistics-2012 update. WHO Cardiovascular diseases (CVDs) ([link] ; accessed June 30, 2020). Circulation. 2012;125(1):e2–e220.

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The Pharma Data

NOVEMBER 9, 2020

” Amgen and AstraZeneca Collaboration Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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The Pharma Data

DECEMBER 21, 2020

Amgen and AstraZeneca Collaboration Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month 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

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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The Pharma Data

NOVEMBER 22, 2020

In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. Merck’s Commitment to HIV.

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Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. Even worse, it showed flaws in our domestic system of drug regulation, notably the Drug Supply Chain Security Act of 2013 (DSCSA). However, to do that, the regulations must prevent the creation of fake DSCSA pedigrees.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. PNAS (2012).

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AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & PNAS (2012).

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Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. Hamilton , 372 S.W.3d 3d 140 (Tex. Well, that’s different. 247d-6d(b)(8).

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Drug & Device Law

NOVEMBER 9, 2023

2012); Amarin Pharma, Inc. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

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Drug & Device Law

JULY 31, 2023

2012), computer code was not a “product” for purposes of the National Stolen Property Act, 18 U.S.C. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2012 WL 5932437 (N.D. 3d 316, 338 (Alaska 2012). 2012 WL 12886210, at *3 (C.D. at 1293-94. Alaska Stat.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. You never need an authorization from a licensed professional to buy pork or fireworks. Ogden , 22 U.S.

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2012) (citing Smith–Haynie v.

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Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. 2012 WL 3265002, at *5 (N.D. Sizemore v.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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