FDA Law Blog: Biosimilars

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. The draft guidance states that a pre-BLA meeting request should be submitted at least 4 months before the anticipated BLA submission.

Documentation

Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Packaging

Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Hospitals

Pharmaceutical Technology

JUNE 24, 2025

Can pharma tariffs “Make America Manufacture Again”? Give your business an edge with our leading industry insights.

Compounding

Pharmaceutical Technology

JUNE 17, 2025

TEV-56278 demonstrates the strength of Teva’s innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients.” ” TEV-56278 has been specifically engineered to target PD-1 + T cells selectively.

Communication

Pharmaceutical Technology

JUNE 27, 2025

Novo Nordisk took a different route with Hims & Hers – the drugmaker partnered with the telehealth company to offer Wegovy via a bundled membership package in April 2025. Mochi Health is even the subject of a lawsuit initiated by Eli Lilly. Give your business an edge with our leading industry insights.

Drug Pricing

Pharmaceutical Technology

JUNE 25, 2025

Over the past few decades, Alzheimer’s research and development (R&D) has seen a low success rate due to failure to demonstrate efficacy in clinical trials. Go deeper with GlobalData Reports Biosimilars in Pharmaceuticals: Peptide-based compositions for Alzh. Give your business an edge with our leading industry insights.

Packaging

PharmaTech

JUNE 20, 2025

Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives. BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools.

Dosage

pharmaphorum

JUNE 27, 2025

The obesity drug market is exploding into a $100 billion opportunity, fuelled by breakthroughs in GLP-1 combinations, novel targets like GIPR modulators, and RNA-based therapies. Get your copy of the event guide to explore the full speaker and sessions lineup: [link] Ready to make your mark on the obesity drugs landscape?

Drug Development

Safe Biologics

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. However, S.6 In conclusion, weakening the interchangeability standard is an unnecessary and potentially harmful step.

Biosimilars

Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

Biosimilars

European Pharmaceutical Review

DECEMBER 13, 2022

Patient-centred pharmaceutical packaging: are we there yet? Interchangeability of biosimilars in the EU – the industry impact. DRUG DEVELOPMENT. Arnaud Robert and Brendan O’Callaghan, Sanofi. Giana Carli Lorenzini, Technical University of Denmark. REGULATORY INSIGHT. Marie Manley and Chris Boyle, Sidley Austin LLP.

Packaging

PharmaTech

JUNE 23, 2025

Among the authorized medicines are six biosimilars and two generic drugs. Drug Solutions Podcast: Growth and Advancements in Fill/Finish Felicity Thomas June 25th 2024 Podcast In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Biosimilars

Pharmaceutical Technology

MAY 23, 2023

The proposed changes aim to reduce the time between new drug launches in the 27 EU markets and the entry of generic competitors into the market. While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

Packaging

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

Packaging

PharmaShots

FEBRUARY 27, 2023

As a renowned chemist, Dr. Senanayake discussed the need to adopt green chemistry in the process of drug development for cost reduction, timely innovation, and generating less waste than the standard process. We can order drugs online and can have online consultations.

Biosimilars

PharmaTech

JUNE 6, 2025

Image source: ©huiying - stock.adobe.com Biopharmaceutical product development is burgeoning with developments in treatment approaches, chemistries, and vectors giving companies new strategies for targeting disease. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1).

Dosage

Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. Solvias is well equipped to provide stability testing for all stages of drug development. HQ ADDRESS: Römerpark 2.

Vaccines

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