Biosimilars, Pharmacokinetics and Therapies

Salt Lake City

Alta Sciences

JUNE 26, 2025

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Pharmacokinetics

Pharmacokinetics Testimonials Biosimilars Drug Development

Gretchen Green

Alta Sciences

JUNE 26, 2025

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Pharmacokinetics

Pharmacokinetics Testimonials Biosimilars Drug Development

Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution

Alta Sciences

JULY 3, 2025

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Marketing

Marketing Pharmacokinetics Testimonials Biosimilars

FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS?

The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”

New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

Vaccine

Vaccine Therapies Immune Response Disease

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. TNB-585 complements Amgen’s existing prostate cancer portfolio, which includes acapatamab (formerly AMG 160) and AMG 509, both in Phase 1. ” In June 2021, AbbVie Inc.

Production

Production Clinical Trials Government Disease

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

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

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

FDA

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA

FDA Science Biosimilars Clinical Trials

The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

Treatment

Treatment Marketing Clinical Trials Biosimilars

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

The Pharma Data

NOVEMBER 6, 2020

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. The safety and tolerability of aducanumab was the primary aim of the study. About Alzheimer’s Disease. About Biogen.

Disease

Disease FDA Clinical Trials Licensing

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

Clinical Trials

Clinical Trials Treatment Therapies Production

Drug Discovery Digest

Salt Lake City

Gretchen Green

Trending Sources

Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution

FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS?

New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

FDA Action Alert: MacroGenics and Amgen

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

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