Generics/General
Sandoz petitions FDA over requirements for generics of Advair Diskus
Sandoz has asked the US Food and Drug Administration (FDA) not to approve generics of GlaxoSmithKline’s (GSK) chronic obstructive pulmonary disorder (COPD) treatment Advair Diskus (fluticasone/salmeterol), unless the generics applications contain the results of pharmacokinetic (PK) bioequivalence studies that ‘ensure the safety and efficacy’ of the products.
Why do generic drug prices keep on rising?
Consumers are paying more and more for their drugs, and especially in the US. The US allows manufacturers to set their own prices for drugs, leading to overall medicine costs being higher than anywhere else. More and more, insurance companies are passing on these higher costs to consumers.
Generics applications under review by EMA – August 2016
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Indian generics manufacturer Lupin buys 21 brands from Japan’s Shionogi
India’s third biggest drug producer Lupin Ltd (Lupin) has announced that it will purchase 21 generic medicine brands from Japanese company Shionogi & Co Ltd (Shionogi) for a total of US$150 million, bolstering its position in the large Japanese pharmaceutical market.
EMA halts sales of unreliable generics
The European Medicines Agency (EMA) has recommended that the sales of several generics, including those produced by Teva and Novartis, be suspended after data on their approval was found to be unreliable.
Extortionate increases in prices of 32 drugs a result of loophole in NHS pricing structure
An investigation by The Times has exposed a small group of UK-based entrepreneurs to have profited vast amounts of money from hiking up the costs of 32 medicines for common conditions by GBP 262 million a year, a 12,500% increase.
Healthcare alliance proposes ways to reduce drug costs in the US
Recent price increases in the US have prompted an alliance of doctors, pharmacists and health plan groups to release a document that outlines 12 policy proposals that it hopes will provide the framework for a major debate in Congress.
China cuts prices for three drugs by more than 50%
In an effort to lower spending on prescription drugs, China has cut the prices for three patent-protected drugs by more than 50%.
Australian generics maker opens clinical trials facility
IDT Australia announced on 2 May 2016 that it had opened a new clinical trials facility in Adelaide.
Generics applications under review by EMA – April 2016
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
