article thumbnail

Adalimumab biosimilars shaping market, research states

European Pharmaceutical Review

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of This has developed following numerous adalimumab biosimilar offerings being brought to market. billion in 2022, a product that was launched in 2002.

article thumbnail

Watch: Blockbuster drug Humira has new competition. Here’s why that matters

STAT

Humira has been the world’s best-selling medicine since it arrived on the market in 2002. Now, it is finally getting competition with the release of Amgen’s biosimilar drug, Amjevita.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Boehringer’s Cyltezo illustrates intersection of price and regulation in biosimilar market: GlobalData

Express Pharma

The potential revenue replacing Humira has resulted in many adalimumab biosimilar offerings being brought forth (currently nine FDA-approved agents), and a rapidly overcrowded market. Against this backdrop, Cyltezo from Boehringer Ingelheim has shown the intersection of price and regulation in the biosimilar market, says GlobalData.

article thumbnail

Watch: Blockbuster drug Humira has new competition. Here’s why that matters

STAT

Humira has been the world’s best-selling medicine since it arrived on the market in 2002. Now, it is finally getting competition with the release of Amgen’s biosimilar drug, Amjevita.

article thumbnail

Three strategies for managing loss of exclusivity successfully

pharmaphorum

6 The stakes were extremely high, with annual costs of insulin reaching $736 per patient in 2013, up threefold since 2002. In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. RESULT: As of 2002, 40% of PRILOSEC patients had switched to NEXIUM, which notched up sales of $3.9 billion in 2004.14

article thumbnail

PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

FDA Law Blog: Biosimilars

Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. However, given FDA’s prior announced policy, it is somewhat surprising that only 16% of pediatric labeling changes pursuant to BPCA and/or PREA between 2002 and 2019 were conducted under both the BPCA and PREA.

article thumbnail

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Some companies accept the offered period and open doors to biological drugs or biosimilars. As of now, there are no the US FDA approved biosimilars available for Actemra. However, last August, Fresenius Kabi announced the US FDA's acceptance of its biosimilar BLA, bringing a potential candidate into the market before long.