Generics
Hospira re-joins Generic Pharmaceutical Association
Hospira announced on 23 February 2012 that the company had re-joined the Generic Pharmaceutical Association (GPhA). Hospira, self-proclaimed leader in injectable generics, added that it is dedicated to ‘advancing wellness’, a goal that matches well with the GPhA’s core purpose of bringing affordable medications to patients who need them.
Apotex clopidogrel at-risk launch costs US$442 million
Sanofi and Bristol-Myers Squibb (BMS) announced on 8 February 2012 that generic drugmaker Apotex had paid a whopping US$442 million in damages in the Plavix (clopidogrel bisulfate) patent infringement case against Apotex.
Prescribing of generic PPIs and statins in Scotland
In Scotland, a series of measures have been introduced since 2000 in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins [1]. Some of the measures introduced include:
Commission urges Greece to make parallel trade fair
The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’.
Sun comes under fire from Pfizer
Sun Pharmaceutical Industries (Sun Pharma) is coming under fire from Pfizer, as the generics major is sued for violating patents on Pfizer’s Protonix (pantoprazole).
WHO definitions of generics
Confusion often surrounds terms used in the global field of generics and biosimilars.
Watson files ANDA for generic Beyaz
Watson Pharmaceuticals (Watson) announced on 10 February 2012 that it had filed an Abbreviated New Drug Application (ANDA) with FDA for a generic version of Bayer HealthCare’s (Bayer) leading oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate).
Italian physicians’ negative attitude to generics
A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.
Sandoz submits ANDA for generic treprostinil
US drugmaker United Therapeutics announced on 6 February 2012 that it had received a Paragraph IV Certification Notice Letter from Sandoz, the generics division of Swiss-based drug giant Novartis. The notice letter stated that Sandoz had submitted an Abbreviated New Drug Application (ANDA) to FDA requesting approval to market a generic version of the 10 mg/mL strength of Remodulin (treprostinil) injection.
Tentative FDA approval for generic HIV treatment
FDA announced on 31 January 2012 that it had given tentative approval for generic versions of GlaxoSmithKline’s (GSK’s) blockbuster AIDs treatment Epzicom (abacavir sulfate and lamivudine). The tentative approval enables India-based generics companies Cipla and Mylan to sell their generics to US aid programmes, but not yet in the US.
