Generics
Generics applications under review by EMA – January 2019
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].
Teva receives FDA approval for Sabril and launches Elidel cream
In January 2019, Teva Pharmaceutical Industries (Teva) received US Food and Drug Administration (FDA) approval for its first generic version of Sabril (vigabatrin) and launched a generic version of Elidel (pimecrolimus) cream, 1%, in the US.
Non-profit generics maker expects first generics in 2019
Non-profit generics company, Civica Rx announced on 7 January 2019 that it expects to launch its first generics during 2019 and has added 12 new member groups representing 250 hospitals.
Sun Pharma gets FDA approval for ganirelix acetate and plans to acquire Japan’s Pola Pharma
Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical company, marks the start of 2019 with two exciting new developments.
Safety of brand-name and generic angiotensin II receptor blockers
Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin II receptor blockers (ARBs) [1].
Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US
India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-release tablets for the treatment of heartburn, and the lifting of a US injunction on its anti-narcotic addiction generic Suboxone (buprenorphine and naloxone).
Sandoz to launch epinephrine in early 2019 at a discount to Mylan and Teva’s generics
Sandoz, the generics division of Novartis, will launch Adamis Pharmaceuticals Corp’s EpiPen (epinephrine) generic Symjepi in early 2019. Symjepi received US Food and Drug Administration (FDA) approval of its 0.3 mg pre-filled single dose syringe in June 2017 [1], and for its lower dose version (0.15 mg) in September 2018. Epinephrine injectors are used for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers. These can include reactions to insect bites or stings, foods, medications, latex or other causes.
FDA approves drug for cancers with specific biomarker
The US Food and Drug Administration (FDA) announced on 26 November 2018 that it had approved Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific genetic feature (biomarker).
Way cleared in US for Suboxone and Zytiga generics
The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction on Dr Reddy’s Suboxone (buprenorphine/naloxone) generic and upheld a decision to invalidate Johnson & Johnson’s (J&J) patent on its blockbuster prostate cancer drug Zytiga (abiraterone).
Glenmark gains FDA approval for MS and pneumonia generics
In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatment of multiple sclerosis (MS) and pneumonia.
