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Biosimilars: Improving Patient Access To Biologics While Bending The Cost Curve

 
• By Joshua Cohen

Zarxio is the first in an expected wave of US biosimilar approvals as blockbuster originator biologics go off patent. Just as market competition for small molecules has proven to be healthy for both generics and brand-name biopharmas, competition for biologics will likely have similar effects.

In 2010, the Affordable Care Act (ACA) established an abbreviated regulatory pathway for biosimilars. The pathway was based on regulations included in 2009 legislation on biosimilars: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA has analogous objectives for large-molecule biosimilars as the 1984 Hatch-Waxman Act had with respect to small-molecule generics. The regulatory pathway is widely expected to speed the development and marketing of biosimilars in the US. In March 2015, the Food and Drug Administration approved Sandoz Inc.'s Zarxio (biosimilar filgrastim) – which is indicated to stimulate bone marrow growth – the first product to successfully complete the new regulatory pathway. Exhibit 1 lists biosimilars on the US market and those expected to be approved and launched in the near future.

Exhibit 1

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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