Generics
Patent challenges in the SADC region
High pharmaceutical prices restrict access to essential medicines. New medicines are often patent protected which sustains prices well above the cost of production. This problem was particularly apparent during the HIV/AIDS crisis in the late 1990s. At this time, 40 million people were believed to be infected with HIV in the developing world and only one in a thousand had access to the required antiretroviral medicines (ARVs). This situation led to conflicts regarding patents for HIV medicines, only a few years after the establishment of the World Trade Organization (WTO) and the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. TRIPS established international standards to protect intellectual property, including a 20-year patent protection for medicines.
Generic irbesartan is safe and effective, shows phase IV trial
Generic versions of the anti-hypertensive irbesartan are equally effective as their branded counterparts, finds a phase IV study conducted in Korea. The study also found that irbesartan is less effective in patients with a high body mass index (BMI) or a history of anti-hypertensive use, suggesting more intensive treatment may be needed in some patients [1].
FDA approves Farxiga generic
The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must be resolved before FDA grants full approval.
Prices for infectious disease treatments and how to reduce them
A recent review from Harvard Medical School explores the factors fuelling high drug prices in the US, suggesting several ways to avoid exorbitant pricing, including increasing clinician awareness of healthcare costs [1].
Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug
On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation technology successfully demonstrated the bioequivalence of a complex generic drug. This has led to US Food and Drug Administration (FDA) approval of the drug on the agency’s abbreviated new drug application (ANDA) pathway.
Generics applications under review by EMA – July 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].
Generic Drug User Fee Act is a benefit to the Indian pharmaceutical industry, study finds
The Generic Drug User Fee Act (GDUFA) has had positive effects on generics manufacturers in India, providing increased return on investment and encouraging compliance with US regulation, recent analysis suggests [1].
Gilead’s Truvada will face generics competition in 2020
Gilead Sciences’ HIV blockbuster Truvada will face generics competition in the US in 2020, a year earlier than expected.
EMA approves two generics for fungal infections
On 29 May 2019, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two new generics for the treatment and prevention of fungal infections, Posaconazole Accord and Posaconazole AHCL.
FDA approval for Unichem Lab’s hydrochloride medicines and Teva’s nasal spray to treat opioid overdose
The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) for their generic hydrochloride tablets, and has approved the first generic naloxone hydrochloride nasal spray, manufactured by Teva Pharmaceuticals (Teva).
