With the release of four different documents around the pricing and use of biosimilars this week, the US CMS (Centers for Medicare and Medicaid Services) is making clear it will fully encourage states to call on prescribers to use cost-effective biosimilars...
More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.
In the ongoing fight over whether US pharmacists will be allowed to prescribe biosimilars in place of their reference products, the Generic Pharmaceutical Association has agreed on “compromise legislation” with innovator manufacturers.
Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.
Like the US and EU, China’s SFDA is looking to ensure that approved biosimilars are proven to be similar to their reference drugs, according to an unofficial translation of the guideline by BioCentury.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Amgen is reviewing data from chronic kidney disease (CKD) patients to assess what impact switching to a 'biosimilar' version of its blood cell booster Aranesp (Darbepoetin Alfa) has had on their disease.