Generics/News
EMA recommends approval of abiraterone and thiotepa generics
In January and February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) held meetings that led to positive opinions towards the recommendation for approval of two generics, Abiraterone Accord (abiraterone) and Thiotepa Riemser (thiotepa).
Teva and Sandoz launch new generics
In early 2021, Teva Pharmaceuticals announced the US launch of generic versions of NuvaRing® and AZOPT®. During the same period, Sandoz launched its version of Firazyr.
EMA recommends approval of fourth COVID-19 vaccine
11 March 2021 saw the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the fourth COVID-19 vaccine. After a thorough evaluation, EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data on the Janssen vaccine were robust and met the criteria for efficacy, safety and quality.
Posaconazole, silodosin and droxidopa generics from Lupin and Sandoz
Early 2021 saw the launch of two generic versions of posaconazole in Canada and the US. In Canada, the first generic version of the drug was launched by pharmaceutical manufacturer Sandoz Canada on 26 January 2021, along with a generic version of silodosin. These launches were followed by the launch of Lupin’s generic posaconazole in the US in mid-February 2021. During the same period, Lupin also announced the US approval of its generic droxidopa capsules [3].
Biocon and Lupin launch generic tacrolimus capsules in US
India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.
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.
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.
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.
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.
