Generics/News
EMA recommends approval for arsenic trioxide and fampridine generics
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).
Mylan launches first generic of Tecfidera in the US
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).
Lupin’s generic diabetes drug approved and asthma drug launched in US
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.
Two additions to the South Korean generics market
In South Korea, a generic drug for the treatment of breast cancer and generic versions of Pfizer’s popular smoking cessation drug, Champix, are soon to become available. These additions to the South Korean market are likely to help it reach the US$20 billion that it is expected to reach in 2020 [1]. This recent leap in its pharmaceutical market size has been spurred on by significant government investments in generics and the fact that many originator drugs lose their patents in 2020, opening the market to generics.
Indian generics makers begin to dispatch remdesivir
Generic drugmakers Hetero and Cipla are among the first Indian manufacturers to dispatch a generic version of the investigational COVID-19 treatment remdesivir, which was originally developed by Gilead Sciences.
Generics of apixaban and chlorzoxazone approved in EU and US
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a generic version of the anticoagulant medicine apixaban. Meanwhile in the US, the Food and Drug Administration (FDA) has approved a generic version of the muscle relaxant chlorzoxazone.
Aurobindo Pharma receives FDA approval for three generics
India-based generics maker Aurobindo Pharma (Aurobindo) has received three approvals from the US Food and Drug Administration (FDA) in recent months, including for its generic versions of guaifenesin, fluoxetine and – via partner company Eugia Pharma – methotrexate.
COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative
Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.
FDA approves Proventil and Daraprim generics
The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.
FDA approves lung cancer and anticoagulant generics
The US Food and Drug Administration (FDA) has issued a final approval for a generic version of Alimta (pemetrexed) and two new generics of Eliquis (apixaban).
