Generics
China prioritizes drug innovation while increasing access to drugs approved abroad
China's pharmaceutical industry is undergoing a transformation towards high-quality and innovation-focused development, which has led to an explosion of new drug and clinical trial approvals in recent years.
Teva launches first Truvada and Atripla generics and two digital inhalers
On 2 October 2020, Teva Pharmaceuticals announced the launch of the first US Food and Drug Administration (FDA) approved generic versions of Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets for the treatment of HIV-1.
Pharmacokinetics and generic drug switching: a regulators view
Researchers from the Netherlands share their view on the pharmacokinetic aspects of generic drug switching, from a regulatory perspective. They argue that there is no reason to change the current average bioequivalence-based approval pathway for generics [1].
EMA recommends approval of Lenalidomide Mylan
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 October 2020 that it recommends granting marketing authorization for the generic medicine Lenalidomide Mylan (lenalidomide).
COVID-19 vaccine progress and FDA approvals for Zydus Cadila
India-based generics company, Zydus Cadila, has had many advancements with product development and approval between August and October 2020. In August, the company announced that its plasmid DNA vaccine to prevent COVID-19 (ZyCoV-D) was found to be safe and well tolerated in the phase I clinical trial. Following this, phase II trials of the vaccine started on 6 August 2020. In October, Zydus Cadila had a number of products approved by the US Food and Drug Administration (FDA) and was launching a forglyn pressurized metered-dose inhaler (pMDI) to treat patients with chronic obstructive pulmonary disease (COPD) in India.
Brazil sees a COVID vaccine setback but treatment advancement
In Brazil’s quest to tackle the COVID-19 pandemic, there has been a volunteer death in a potential vaccine trial, but a potential treatment option has emerged. Brazil has the second number of COVID-19 deaths, with over 159,033 deaths recorded up to end of October 2020.
FDA approves Glenmark and Cipla generics
Glenmark Pharmaceuticals and Cipla Limited have announced that they have received US food and Drug Administration (FDA) approval to market their generic drug products in the US. Both companies have received approval to market dimethyl fumarate delayed-release (DR) capsules and Glenmark also received approval to market Sirolimus tablets.
Reforms to health policy needed in Europe
The President of Medicines for Europe has made four key recommendations for European Union (EU) pharmaceutical policy, while the Irish Pharmacy Union (IPU) says reforms to the health service could save Ireland millions of euros.
Medicare Part D favours generics over brand-name drugs
A recent assessment of Medicare Part D [1] finds that insurance plans favour generic drugs over innovator products. Fewer than 1% of plans covered only the brand-name version of a drug in 2019.
Sun Pharma launches Ilumya in Japan and favipiravir in India
Sun Pharmaceutical Industries Inc (Sun Pharma) announced that their innovative biopharmaceutical product, Ilumya (tildrakizumab), will be launched in Japan. As a producer of generics, rather than biologicals, this is an important milestone for the company. This launch joins Sun Pharma’s August 2020 launch of favipiravir for treatment of COVID-19 patients at a very economic price in India.
