Generics
Germany tightens controls on pharmaceutical prices
The German government is contemplating pharmaceutical price control legislation as it battles soaring drug spending. On the one hand Germany is keen to promote the use of generic drugs and generic medicines have already achieved high penetration—75% by volume in 2009. This highlights opportunities for generic manufacturers in Europe's largest, albeit competitive, drug market.
Topotecan market too hot for Sun
Sun Pharmaceutical Industries withdrew its marketing authorisation application for Topotecan SUN on 17 February 2011. EMA was formally notified by Sun of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Topotecan SUN 1 mg and 4 mg powder for concentrate for solution for infusion.
Brand-name versus generic drug costs
The Blue Cross Blue Shield of Michigan, an American healthcare insurance company, has collected data on the top 25 brand-name drugs with available generic counterparts.
India under attack
India is coming under attack from Big Pharma from all angles it seems. On the one hand the Indian Government has alleged that multinational companies are campaigning against the country’s domestic pharmaceutical industry due to India’s increasing generic global presence. Then on the other hand Novartis has been asked to end its challenge to Indian patent law, with claims that its action could hinder global access to medicine.
Value-based pricing – the concept
The concept of value-based pricing (VBP) is outlined. A key purpose of the VBP system is to assess over time whether the drug has achieved its intended goal and justified its cost.
EU-India free trade agreement and impact on generics
Opposition is mounting against the imminent EU-India free trade agreement (FTA) from both AIDS activists and industry. Protestors claim that the agreement will harm access to affordable medicines.
Indian generics companies to strengthen in 2011
Dispute with EU resolved
The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.
Sun Pharma continues to expand its generics portfolio
Sun Pharma is keeping up the momentum in the generics market with several new generics recently gaining FDA approval and with an extensive pipeline on the way. The latest generics to come out of the company include drugs for the treatment of hypertension, allergic rhinitis and depression.
Strong lobbying by Canadian Generics Association
The President of the Canadian Generic Pharmaceutical Association (CGPA), Mr Jim Keon, has been speaking up on behalf of Canadian generic companies in two recent statements. Canada and the EU are currently in negotiations for a comprehensive economic and trade agreement, which they hope to conclude before the end of 2011.
European Parliament gives go-ahead for EU patent
Despite doubts over the legality of the proposed linguistic regime, the European Parliament gave its green light on 15 February 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.
