FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. AbbVie), for a direct-to-consumer (DTC) TV advertisement for its drug UBRELVY (ubrogepant) that features tennis star, social media influencer and entrepreneur Serena Williams.

Labelling 59

Labelling Adverse Reactions Dosage 59

Big Molecule Watch

MARCH 1, 2024

As background: the IRA defines “qualifying single source drugs” as drugs that are, among other things, (a) approved or licensed under the NDA or BLA provisions of the FDCA or BPCIA and (b) not the reference product for any generic or biosimilar that is “approved and marketed” (or “licensed and marketed”) pursuant to an ANDA or aBLA.

Biosimilars 59

Biosimilars Drug Pricing Dosage Documentation 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

Dosage 59

Dosage Drug Pricing Pharmaceutical Manufacturing 59

Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

Biosimilars 58

Biosimilars Dosage Drug Pricing 58

FDA Law Blog: Biosimilars

JULY 1, 2024

Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).

Dosage 52

Dosage Controlled Substances 52

Pharmaceutical Technology

NOVEMBER 3, 2022

According to the agency, shortages of both drugs are expected to last until 2024, as a result of growing demand. As of November 2, different dosage forms of the treatment remain on the FDA’s drug shortages list due to manufacturing challenges, with estimated recovery dates in March, June, and September 2023. Improving the supply chain.

Dosage 111

Dosage Biosimilars Documentation Hospitals 111

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

There have already been (with more coming) a slew of 40th anniversary celebration papers, analyses, and events in 2024, including: The Brookings Institution’s Hatch-Waxman at 40 The Association for Accessible Medicines’ Hatch-Waxman turns 40. And that name has stuck for many of us. Is it over the hill? (Or

Dosage 59

Dosage Drug Pricing 59

FDA Law Blog: Biosimilars

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). Immediate-Release and High Dosage Opioids The government’s expert asserted that opiate prescriptions alone can create a “therapeutic duplication” red flag when two separate immediate release opioids are prescribed in their highest strength version. Coconut Grove Pharmacy; Decision and Order, 89 Fed.

Controlled Substances 52

Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

MARCH 12, 2024

Each made similar points as the 3 that did delist: patents that claim the finished dosage form must be listed in the Orange Book, and the referenced patents claim the finished dosage form. FTC’s and Congress’s activities seem to have triggered litigation.

Dosage 45

Dosage 45

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.

Dosage 59

Dosage 59

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. It acts as a mobilization agent and should be injected subcutaneously with dosage depending on body weight. As of now, there are no the US FDA approved biosimilars available for Actemra.

Biosimilars 49

Biosimilars Diabetes Chemotherapy Immunity 49

FDA Law Blog: Biosimilars

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. at least one drug” has been approved and marketed.

Dosage 64

Dosage Drug Pricing 64

FDA Law Blog: Biosimilars

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. Thirty-eight states currently authorize marijuana in different dosage formulations for specific qualifying medical conditions.

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. This came after an attempted sell-off starting last October was met with no formal offers from a buyer.

Biosimilars 64

Biosimilars Drug Development Vaccines Dosage 64

FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. §

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. By Deborah L.

Pharmacy Management 111

Pharmacy Management Dosage Documentation 111

FDA Law Blog: Biosimilars

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Three Republican senators on the Foreign Relations Committee advised to consider U.S.

Controlled Substances 95

Controlled Substances Chemotherapy Dosage Labelling 95