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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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

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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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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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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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

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

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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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

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

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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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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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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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

MARCH 7, 2024

Led by Annie Kennedy, Everylife’s VP of Government Affairs and Policy, we worked the halls of Congress to educate lawmakers on the pressing needs of the rare disease community. I currently serve as Vice Chair of the Board of the Everylife Foundation. Last Wednesday, the White House hosted its first ever rare disease event.

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FDA Law Blog: Biosimilars

MARCH 22, 2023

In a recent trial, a jury verdict finding $43M in single damages has, according to the government , resulted in $490M in statutorily mandated liability. The sheer size of that type of exposure gives the government and relators an outsized hammer in negotiating with a putative or actual defendant.

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FDA Law Blog: Biosimilars

MAY 15, 2024

On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests ( LDTs ). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring significant operational changes and posing strategic challenges for many LDTs.

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FDA Law Blog: Biosimilars

JULY 30, 2024

Women in Government and Judiciary Roundtable. We heard multiple speakers acknowledge that Loper Bright will invite more challenges to government regulation and the need for federal agencies to shore up their rules and regulations to protect past actions and reduce the ripple effects for regulated entities.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

According to the court, AstraZeneca’s “desire” or even “expectation” to sell its drugs to the Government at the higher prices it once enjoyed does not create a protected property interest.” The court reasoned that no one is entitled to sell to the Government at prices the Government will not agree to pay.

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The Pharma Data

OCTOBER 27, 2020

Commenting on his appointment, Parag Agarwal said, “Dr Reddy’s is driven by its purpose, high governance standards, a robust strategy and strong leadership. Saumen will continue to be associated with the Company as an Advisor. He will also help Parag to transition effectively. Dr. Reddy’s operates in markets across the globe.

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FDA Law Blog: Biosimilars

JUNE 7, 2023

to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value. The complaint characterizes this as political deception that conscripts companies to legitimize government extortion. Complaint at 2. Complaint at 3.

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

FDA’s proposed rule, and the industry fervor it has sparked, may supply Congress with a renewed sense of urgency and purpose to pass legislation that expressly addresses how LDTs should be regulated—industry groups have, for example, proposed legislation that would modernize the CLIA regulations that currently govern laboratories.

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FDA Law Blog: Biosimilars

MAY 9, 2023

The news wasn’t all bad for the government, but FTC’s now has some decisions to make. But the judge also dealt a blow to the government, dismissing its suit against Kochava. So, the government here has a choice to make. In this case, the potential for harm was not enough to sustain the suit.

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FDA Law Blog: Biosimilars

JUNE 3, 2024

Wasserstein — Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case , and may bring about a clash between what many companies do and what the government may be objecting to. Or, perhaps your loyal blogger is reading too much into a brief settlement document.

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The Pharma Data

SEPTEMBER 17, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. government, we could become subject to significant sanctions.

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The Pharma Data

MARCH 5, 2021

To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines.

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