FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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The Pharma Data

JANUARY 24, 2021

Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The results of the study were published in the Journal of Clinical Oncology in August 2019. and a disease control rate (DCR) of 86.2%

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The Pharma Data

OCTOBER 29, 2020

million , a 26 percent increase compared to the same period in 2019. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. million in the third quarter of 2019. million in the third quarter of 2019, representing a 5 percent increase. in the prior year.

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Agency IQ

SEPTEMBER 22, 2023

The goal of the framework , as described in a 2019 presentation from FDA staff on the subject, is to “provide prescription drug sponsors the flexibility to disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors’ communications about their products.”

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Central time.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The guidance, is an overdue requirement of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The guidance, is an overdue requirement of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019.

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The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. The Alzheimer’s Disease International 2019 Alzheimer’s Yearbook estimates that approximately 10 million people in the EU suffer from dementia (excluding Mild Cognitive Impairment). Since October 2017 Biogen and Eisai Co.,

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Agency IQ

SEPTEMBER 29, 2023

The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Penalties for “Misclassification” The Medicaid Services Investment and Accountability Act of 2019 added new penalties to the Medicaid rebate statute for knowingly misclassifying a covered outpatient drug. If a manufacturer terminates the NRA for one of its labeler codes, CMS will terminate all of the manufacturer’s NRAs for all labeler codes.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. percent on a reported basis, or 12.6

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

FEBRUARY 8, 2021

to €131 million and 12.2%, respectively and benefited from increased demand in metastatic castration-resistant prostate cancer following publication of the results of the CARD study in this disease setting at ESMO (European Society for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. In the U.S.,

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The Pharma Data

FEBRUARY 4, 2021

to €131 million and 12.2%, respectively and benefited from increased demand in metastatic castration-resistant prostate cancer following publication of the results of the CARD study in this disease setting at ESMO (European Society for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. In the U.S.,

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The Pharma Data

APRIL 27, 2021

net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). due to the earlier supply to the market as compared to the 2019/2020 flu season. In the U.S., Toujeo ® sales were stable with volume growth offsetting average price decrease.

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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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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 December 2019; and. First-quarter 2021 operational growth was primarily driven by: BNT162b2, which contributed $3.5

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2019 May 23;380(21):2082]. Allergol Int 2019; 68: 158–66. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected.

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Agency IQ

DECEMBER 1, 2023

The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

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The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2019 May 23; 380 (21): 2082]. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Front Immunol. 2018; 9: 1595.

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