Executive Summary US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.
Executive Summary 'We have about 18 different projects underway but we've achieved' only one value-based deal, Pfizer CEO Ian Read says. 'The risks and incentives have to be with the providers. … That's how you get the best health care.'
Executive Summary The spate of recent warning letters going to foreign pharmaceutical manufacturers continues as two Asian firms get into trouble for GMP violations: Firson Co. in South Korea and Wuxi Medical Instrument Factory in China.
Executive Summary Changes have been proposed to the international guideline on the methodologies that drug companies should use to test medicinal products to assess the risk of reproductive toxicity. The revised guideline takes into account new testing paradigms that allow enhanced human risk assessment and reduced animal use.
Executive Summary Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.
Executive Summary New drug submissions to the Australian TGA remained at the same level in 2016-17 as in the previous year, while the number of generic filings fell significantly. Extension of indications applications were up noticeably, as were adverse drug reaction reports for medicines and vaccines.
Executive Summary Mexico, Turkey and Iran will start participating in the international Pharmaceutical Inspection Cooperation Scheme as of January 2018. Meanwhile, Russia has become the latest country to apply to join the scheme.
Executive Summary Samsung Bioepis’s Ontruzant is set to be the first biosimilar version of Roche’s Herceptin on the EU market after getting the all-clear from the EMA’s CHMP on Sept. 15. The committee has also OKd another version of AbbVie’s Humira, this time from Boehringer Ingelheim.