The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. When compared to the year immediately prior to the pandemic, however, 2023 actually marks an increase in volume, with only 70 opinions issued in 2019. Reviews of orphan medicines and biosimilars have remained stable over the past three years.

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

OCTOBER 29, 2020

million , a 26 percent increase compared to the same period in 2019. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. million in the third quarter of 2019. million in the third quarter of 2019, representing a 5 percent increase. in the prior year.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Central time.

Production 52

Production International Clinical Trials Small Molecule 52

Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). First-quarter sales in the U.S.

Vaccine 52

Vaccine Production FDA FDA Approval 52

Agency IQ

DECEMBER 1, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40