The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability. Biogen Inc.

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Drug Channels

FEBRUARY 21, 2024

Below, I explain why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs , even as the government and manufacturers will prefer a low-list-price version. Just another IRA-inflicted hit for biosimilars? The warped incentives don't stop there.

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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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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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FDA Law Blog: Biosimilars

JUNE 12, 2024

HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Hyman, Phelps & McNamara, P.C. (HP&M)

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC.

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Drug Channels

JULY 11, 2022

President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S.

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The Pharma Data

MAY 31, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.

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Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Complaint ¶ 55.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

As to biosimilars, FDORA amends the statutory language regarding criteria for the demonstration of biosimilarity for a 351(k) biologic. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).

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FDA Law Blog: Biosimilars

MAY 4, 2025

The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China. Both chemicals are used in the illicit manufacturer of fentanyl. from China and transshipped to Eagle Pass for export to Mexico for manufacturing fentanyl.

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FDA Law Blog: Biosimilars

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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Drug Channels

JUNE 5, 2023

Join peers this August to discover the evolving specialty pharmacy marketplace, build multi-stakeholder partnerships, and explore frameworks to inform your 2024 distribution and patient service strategies.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

While on paper the respective credentials of each of the experts would indicate a balance of authority, or maybe even weigh in favor of the pharmacys expert (DEAs expert had prior disciplinary history), the ALJ and DEA Administrator each found the testimony of the governments expert more credible. Whats the take away?

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. The government charged these individuals with conspiracy (18 U.S.C. §

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

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Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Most FDA user fee amounts are published at a regular cadence. Read AgencyIQ analysis here.]

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S.

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FDA Law Blog: Biosimilars

MAY 15, 2025

FDA Law Blog readers are offered a discount of 10% off the registration price.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

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FDA Law Blog: Biosimilars

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines.

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Drug Patent Watch

JANUARY 7, 2025

Public Awareness Campaigns Encourage government-sponsored public awareness campaigns about the safety and efficacy of generic drugs. “2021 Generic Drug & Biosimilars Access & Savings in the U.S. Formulary Design Advocate for health insurance formularies that prioritize generic drugs when appropriate. Kesselheim, A.S.,

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. A complete agenda is available here.

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FDA Law Blog: Biosimilars

MAY 19, 2025

Press Release , Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S. Attorneys Office, Northern District of Illinois, April 21, 2025.

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The Pharma Data

MAY 18, 2021

In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. About Sandoz.

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FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M.

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

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The Pharma Data

APRIL 6, 2021

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). In the United Kingdom, this announcement is directed only at persons who are “qualified investors” within the meaning of the UK Prospectus Regulation.

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DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets.

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FDA Law Blog: Biosimilars

JUNE 8, 2023

The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic had changed the way people live, work and communicate. Such changes are not limited to personal circumstances. One distinct change has been the rise of conducting meetings over digital platforms. However, not all changes are forever.

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The Pharma Data

APRIL 8, 2021

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). In the United Kingdom, this announcement is directed only at persons who are “qualified investors” within the meaning of the UK Prospectus Regulation.

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FDA Law Blog: Biosimilars

JULY 8, 2024

According to the dissent, where the government is the claimant, it concerns a public right. As the dissent points out, the federal government has operated for decades on the assumption that many disputes can be adjudicated by ALJs. So the SEC has the option of retrying Jarkesy in a district court.

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