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 130

Biosimilars Drug Pricing Packaging Labelling 130

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 130

Biosimilars Packaging Labelling Drug Development 130

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 82

Packaging Biosimilars Drug Development 82

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 52

Vaccines Biosimilars Compounding Packaging 52

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 59

Packaging Documentation Labelling Communication 59

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 64

Packaging Drug Development Documentation 64

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 52

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Packaging 52