FDA Law Blog: Biosimilars

JULY 18, 2023

Those include biological products licensed under Biologics License Applications (BLAs), approved drugs under New Drug Applications (NDAs), and generic products under approved Abbreviated New Drug Applications (ANDAs). Four specific kinds of events comprised over a third of the 900+ recalls.

FDA

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. Teva Pharmaceutical Industries Ltd.

Pharmaceuticals

FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

FDA

The Pharma Data

SEPTEMBER 16, 2020

Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. Our stock price is volatile and may be affected by a number of events.

Clinical Trials

The Pharma Data

JULY 27, 2021

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Our stock price is volatile and may be affected by a number of events.

Production

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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.

FDA

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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.

FDA

The Pharma Data

SEPTEMBER 20, 2020

No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar.

Clinical Trials

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. The following PDUFA dates were obtained from publicly available sources.

FDA

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. Recent Events. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent, with U.S. AbbVie Inc.

Production

The Pharma Data

NOVEMBER 9, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Trials

BioPharma Drive: Drug Pricing

JULY 21, 2025

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). What is the impact of vertical integration, the IRA and other factors on biosimilar adoption?

Biosimilars

The Pharma Data

OCTOBER 29, 2020

ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

Clinical Trials

The Pharma Data

DECEMBER 21, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Trials

The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. Recent Events. 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. AbbVie Inc.

FDA

Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” In May 2023, the MHRA revealed which regulators will be included in the scheme: Australia, Canada, the E.U.,

International

FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S.

Biosimilars

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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.

FDA

The Pharma Data

AUGUST 3, 2021

– Notable pipeline events included positive data readouts for tirzepatide for type 2 diabetes and Jardiance for adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). . Key Events Over the Last Three Months Regulatory. 23% Net Income – Reported 1,390.2 2)% EPS – Reported 1.53

Production

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.

FDA

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.

Biosimilars

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease

The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . The restriction will apply for two years. . EMA Report. .

Pharmaceuticals

The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s. Since October 2017 Biogen and Eisai Co.,

Disease

The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s. Since October 2017 Biogen and Eisai Co.,

Clinical Trials

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. During the clinical development stage, Molecular Partners will provide clinical supply.

Therapies

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.

FDA

DrugBank

DECEMBER 4, 2024

Still, it also provides flexibilities, such as compulsory licensing and parallel importation, that LMIC can utilize to improve access to medicines. The MPP's model of voluntary licensing has been hailed as a successful example of how intellectual property rights can be leveraged to promote public health goals.

Drugs

Agency IQ

JUNE 2, 2023

They might be required as part of a product’s Risk Evaluation and mitigation Strategy (REMS) or if they are deemed necessary to prevent serious adverse events, inform patients on the potential for serious side effects, and/or inform a patient on the importance of medication adherence to ensure a medication’s effectiveness.

FDA

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. Of note: A government shutdown would likely delay or cancel some of the events listed below.

FDA

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.

FDA

The Pharma Data

FEBRUARY 8, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Board meeting held on February 4, proposes annual dividend of €3.20.

Vaccine

The Pharma Data

FEBRUARY 4, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Board meeting held on February 4, proposes annual dividend of €3.20.

Vaccine

The Pharma Data

APRIL 27, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (2) at CER, barring unforeseen major adverse events. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). 3) within 24 hours of either the TIA or IS event.

Vaccine

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. billion due to recent and expected generic and biosimilar competition for certain products that have recently lost or are anticipated to soon lose patent protection.

Vaccine

FDA Law Blog: Biosimilars

JANUARY 9, 2024

This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. based entity licensed as a wholesale distributor or a pharmacist that will import the drugs. This must be a U.S.-based

FDA Approval

FDA Law Blog: Biosimilars

MARCH 31, 2025

1096 , the Preserve Access to Affordable Generics and Biosimilars Act ; and (2) S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills weve seen before: (1) S. 1095 , the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act).

Biosimilars