Pharmaceutical Technology

MAY 19, 2023

Rinvoq is a major pillar in AbbVie’s plan to stem revenue drops once biosimilars to its behemoth Humira (adalimumab) enter the market on a sustained basis this year. AbbVie anticipates Rinvoq sales to exceed $7.5bn in 2025 and for the peak revenues from both drugs to exceed Humira’s peak sales by 2027.

Mayo Clinic 105

Mayo Clinic Dosage Biosimilars Immunity 105

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

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.

Dosage 64

Dosage Drug Pricing 64

Express Pharma

NOVEMBER 26, 2024

.” Dr Veeramani, Chairman, Pharmexcil, said “ The Indian pharmaceutical industry stands as a global leader, exporting to over 200 countries and providing comprehensive solutions across APIs, finished dosages, clinical research, and pharmacovigilance. With exports nearing $27.84

Packaging 105

Packaging Biosimilars Pharmaceutical Manufacturing Dosage 105