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.

Biosimilars 59

Biosimilars Packaging 59

RX Note

DECEMBER 11, 2023

Some medications are supplied in amber (light-protected) vials, while others are stored in the original packaging (foil overwrap or box) until needed. Many medications should be protected from light during storage to avoid degradation.

Packaging 40

Packaging Biosimilars 40

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. 2022 [cited 2023Feb]. the enteric coating and the capsule dissolve.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M. s John W.M.

Packaging 59

Packaging Labelling 59

pharmaphorum

JANUARY 27, 2023

It’s wise advice from the “Sage of Omaha”; indeed, one highly respected financial newspaper began its 2023 predictions by conceding that it had been wrong on five major counts for 2022. The same goes for many commodities used in the production process for key medicines, from solvents through to packaging.

Packaging 105

Packaging Biosimilars Vaccines 105

Pharmaceutical Technology

NOVEMBER 14, 2022

The British pound fell to its lowest level ever against the dollar on September 26, 2022, in reaction to the former UK chancellor Kwasi Kwarteng’s £45bn tax-cutting package, when one dollar equated to £0.92. Rishi Sunak became the British prime minister on October 25, 2022.

Packaging 59

Packaging Biosimilars 59

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. On-site Evaluations.

Labelling 98

Labelling Packaging Biosimilars 98

FDA Law Blog: Biosimilars

MARCH 8, 2023

Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023. This was deployed to pre-production on August 19, 2022 and implemented in eMDR and eSubmitter the same day.

Packaging 59

Packaging Communication 59

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

Labelling 59

Labelling Packaging Documentation 59

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

Documentation 75

Documentation Packaging Communication Labelling 75

Pharmaceutical Technology

DECEMBER 9, 2022

Rankings 2022. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings.

Vaccines 52

Vaccines Biosimilars Compounding Packaging 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

Packaging 59

Packaging Documentation Labelling Communication 59

PharmaShots

FEBRUARY 27, 2023

Manan Sharma- “as from the technology side I will start with the recently used cases like the government of India has already made it mandatory for around 300 drugs to have their barcode on the packaging to track and trace the information of the drugs. We can order drugs online and can have online consultations.

Biosimilars 40

Biosimilars Diabetes Packaging Hospitals 40

RX Note

FEBRUARY 23, 2023

Figures - Elemental iron and calcium content?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Safe Biologics

AUGUST 23, 2024

as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,

Biosimilars 130

Biosimilars Chemotherapy Packaging 130

FDA Law Blog: Biosimilars

MARCH 9, 2025

The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, and new FTC advertising guidelines.

Packaging 59

Packaging 59

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect.

Controlled Substances 59

Controlled Substances Packaging Labelling Hospitals 59

pharmaphorum

JANUARY 22, 2021

What this means for the pharma industry is likely business as usual, at least until the midterm elections in 2022.” . “As ever, it takes a “supermajority” of over 60 votes to get any major legislation through the Senate, so longer-term Democratic wishlist items like a public option or single payer are unlikely.

Drug Pricing 63

Drug Pricing Packaging Biosimilars Pharmaceutical Companies 63

FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

Packaging 64

Packaging Drug Development 64