Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

Biosimilars 72

Biosimilars Labelling Diabetes 72

FDA Law Blog: Biosimilars

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

Labelling 72

Labelling Documentation Communication 72

pharmaphorum

AUGUST 3, 2022

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. Roche has US marketing rights to the drug, and booked $1.3

Biosimilars 59

Biosimilars Diabetes Labelling 59

FDA Law Blog: Biosimilars

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. The OTC approval of NNS will not change the prescription status of the 21 injectabl e naloxone products listed in the Orange Book.

Labelling 105

Labelling 105

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JANUARY 1, 2025

Teva , the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead? ). The safe harbor applies only when the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent.

Labelling 105

Labelling Biosimilars 105