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 .
India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.
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.
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).
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.
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 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.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting marketing authorization for two generic medicines: arsenic trioxide medac (arsenic trioxide) and Fampridine Accord (fampridine).
On 19 August 2020, Mylan announced the launch of the first US Food and Drug Administration (FDA) approved generic of Biogen's multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate).
In August 2020, India-based generics maker Lupin announced that it has received approval from the US health regulator to market a generic diabetes drug in America. Following previous US Food and Drug Administration (FDA) approval, it has also now launched generic tablets for the treatment of asthma in the US market.