article thumbnail

Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation

The Pharma Data

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

article thumbnail

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

The Pharma Data

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

article thumbnail

Excellence Awards 2022 – Winners Announced!

Pharmaceutical Technology

Financing recognises companies and institutions that have raised significant capital during the research period whether it be through corporate finance, the capital markets or fund raising. The category includes any projects that demonstrate an innovative approach to the market.

Insulin 130
article thumbnail

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

Sandoz’ Hyrimoz 50 mg/mL was first approved by the European Commission in July 2018 and launched in several European countries shortly thereafter. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

article thumbnail

Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

XTalks

Sandoz is a pioneering leader in generic pharmaceuticals and biosimilars, as Sandoz launched the world’s first biosimilar in Europe in 2006 and won the first biosimilar approval in the US in 2014. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar. billion in 2021 to a high of $44.7

article thumbnail

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

We delve into the driving forces behind their successes and shed light on the groundbreaking research that has earned them a place among the elite in the pharmaceutical arena. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

Sales 98