Generics
New indication for old generic combination drug
US biopharmaceutical company Avanir Pharmaceuticals has announced positive results from a phase II clinical trial of a generic combination drug for the treatment of agitation in patients with Alzheimer’s disease. The same combination is already approved for a different neurological disorder, and other indications are being investigated.
The ethics of generic immunosuppressive drugs
A literature review of generic immunosuppressive drugs (ISDs) in renal transplant patients concludes that it is ethical to prescribe generic ISDs provided regulatory safeguards are met. Alongside these safeguards, it will be essential to educate patients and to carry out further clinical and health economic studies to inform clinicians, patients and society of the risks and costs of drug substitution [1].
Phase III trials for generic asthma inhaler and insulin glargine
Generics giant Mylan is set to embark on phase III clinical trials of its generic fluticasone/salmeterol inhaler for asthma patients.
Generics taskforce for Australia
Australia’s Generic Medicines Industry Association (GMiA), which represents companies that manufacture, supply and export generics, has called on the country’s Minister for Industry to convene a Medicine Manufacturing Taskforce.
FDA approvals for generic AIDs and testosterone drugs
The US Food and Drug Administration (FDA) has approved generic versions of drugs to treat appetite loss in AIDs patients and a testosterone gel treatment for men.
Generics applications under review by EMA – August 2014
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].
Pharma’s future in China and the US
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 physicians will keep the share of patented drug sales high compared with countries that have more direct government control over the pharmaceutical market [1].
Generic hepatitis drug to be made available to 80 countries
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 developing countries including India, Indonesia, and Pakistan, as well as Egypt, Mongolia, South Africa, and Vietnam.
Teva wins another Symbicort patent challenge
Teva Pharmaceutical Industries (Teva) has gained another win in its campaign to launch a generic version of AstraZeneca’s asthma and chronic obstructive pulmonary disorder (COPD) treatment Symbicort (formoterol/budesonide) in Europe.
Appropriate generics pricing improves medicines availability in Sri Lanka
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-communicable diseases (NCDs) in the country.
