News

Concerns from EU and US over Colombian biologicals guidelines

Published on 2015/05/26

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including 'product...

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Generics group calls for say on ICH standards

Published on 2015/05/22

The generics industry is somewhat annoyed at being excluded from the decision-making process of a global organization, which harmonizes drug quality, safety and efficacy standards. The In...

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Generic hepatitis drug to be made available to 80 countries

Published on 2015/05/20

Originator pharma company Gilead Sciences (Gilead) is reportedly close to reaching a deal with generics makers to bring low cost versions of its hepatitis C drug Sovaldi (sofosbuvir) to about 80 d...

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Pharma’s future in China and the US

Published on 2015/05/18

Although generics will increase their share of all prescriptions in China and the US over the next 10 years, economic and structural incentives for new drug invention and brand-name prescribing by...

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FDA debuts purple book for biologicals and interchangeable biosimilars

Published on 2015/05/14

On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Purple Book’, a new set of lists of licensed biological products and ...

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Regulating the safety of biosimilars

Published on 2015/05/12

Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety assessment of biosimilars has been prepared to assist all those interested...

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Adalimumab biosimilar has comparable pharmacokinetics to Humira

Published on 2015/05/08

An adalimumab biosimilar (CHS-1420) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study. Coherus announced on 14...

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Appropriate generics pricing improves medicines availability in Sri Lanka

Published on 2015/05/06

The wide availability of generics across Sri Lanka, in both private and semi-government community pharmacies, is increasing the availability and affordability of essential medicines for non-commun...

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Physicians believe biosimilars should have different names

Published on 2015/05/04

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion. On 14 August 2014, more than 10 medical associations and 20 individual sp...

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Value of generics overlooked in one country that needs them most: Greece

Published on 2015/04/30

A study of physicians’ prescribing patterns and perceptions towards generics in Greece has revealed a clear need for an appropriate regulatory framework and organized generic drug industry in th...

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ECCO survey highlights lack of confidence in biosimilar mAbs

Published on 2015/04/28

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on 18 March 2014 in Brussels, B...

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Trends in the financial burden of diabetes treatment

Published on 2015/04/23

The number of adults diagnosed with diabetes in the US increased 75% between 2000 and 2010, resulting in 9% of the adult population with diabetes. The cost of health care for people with diabetes ...

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