Generics
Sun Pharma and Dr Reddy’s generics progress in EU and US
October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.
High price of cancer medicines make treatment unaffordable globally
Cancer is the leading cause of death worldwide. Currently, there are increasing concerns about the price of cancer medicines and how this can limit patient access to lifesaving treatments. Now, a new study published in Applied Health Economics and Health Policy [1] calls for strengthened pricing policies that can ensure affordable cancer treatment for all.
Oncology generics launched by MSN Labs and Natco Pharma
In late September 2021, MSN Labs launched Cabolong, a branded generic of Cabozantinib for treatment of renal cell carcinoma in India. This was followed by the early October announcement that in the US, Natco Pharma launched 10 mg strength everolimus tablets, an oncology generic of Novartis’ Afinitor.
US brand-name drug market exclusivity periods remain relatively unchanged over the past decade
The passage in 1984 of the Hatch-Waxman Act set into motion sweeping changes to the US brand-name and generic drug competitive environment. It greatly increased generic drug competition for small-molecule drugs, by establishing a new abbreviated new drug application (ANDA) generic drug approval process that substantially reduced the time and cost associated with a generic drug marketing application submitted to the US Food and Drug Administration (FDA). In addition, it created incentives for challenges to brand-name drug patents, while also creating incentives for continued medical innovation and new drug development by drug innovators.
Considerations for the evaluation of generic IUDs containing levonorgestrel
Fertility regulation benefits the population, protecting the right to life and health, supporting the right of individuals to enjoy their sexuality and the right of children to be born wanted. In addition, it safeguards people’s freedom of conscience to decide whether or not to use a contraceptive method, based on their personal values, safeguards the principle of non-maleficence and the principle of equity and justice. This is fulfilled when services are universally accessible without discrimination and authorities monitor that this condition is respected. Currently, different types of contraceptive methods are available, which are classified into hormonal, barrier, long-acting reversible contraception, emergency contraception and sterilization. All of them must meet the basic conditions of efficacy, safety, acceptability, availability and reversibility.
New five-year medicines agreements in Australia
The Australian Government has entered into five-year strategic agreements with Medicines Australia and the Generics and Biosimilar Medicines Association (GBMA), to improve access to affordable, innovative, and life-saving therapies, vaccines and medicines.
Generic pharmaceutical policies in the MENA region
Healthcare systems in the Middle East & North Africa (MENA) region face challenges in service funding and delivery with policy emphasis in the region currently focused on controlling pharmaceutical expenditure. A key component of pharmaceutical cost-containment is a strong policy for generics aiming to improve uptake and access.
Sandoz launches ferumoxytol and pemetrexed generics
Sandoz has launched ferumoxytol iron deficiency anaemia (IDA) treatment in the US and pemetrexed oncology treatment in Europe.
Generics applications under review by EMA – July 2021
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].
The generics market in Brazil
The Brazilian pharmaceutical market has undergone many changes since the introduction of generic drug laws.
