Generics

Market evolution of new drug formulations

Generics/Research | Posted 01/04/2019

Brand-name drug manufacturers sometimes create modified versions of their approved drugs which can include new strengths, dosage forms, or delivery routes. This product modification can meaningfully increase patient treatment options; however, some cases have come under scrutiny as they do not offer any clear therapeutic advantages. This second practice is a form of ‘product hopping’, a method used by manufacturers to prolong revenue streams related to market exclusivity. Complementary strategies such as product discontinuation can augment the impact of product hopping.

Factors associated with increased side effects and lower perceived efficacy when switching to a generic

Generics/Research | Posted 22/03/2019

In 2017, the New Zealand Pharmaceutical Management Agency (PHARMAC) changed the funded version of the antidepressant venlafaxine from Efexor XR (the branded originator) or Arrow-Venlafaxine XR (a generic version) to a new generic, Enlafax XR. MacKrill and Petrie examined differences in preferences and perceptions between patients switched from the originator branded venlafaxine to the new generic, and those switched from the old generic version [1]. Specifically, they investigated the factors associated with preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic.

FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA

Generics/News | Posted 22/03/2019

In January 2019, the US Food and Drug Administration (FDA) approved Amneal Pharmaceutical’s (Amneal) generic Exelon patch and Dr Reddy’s Laboratories (Dr Reddy’s) Tosymra nasal spray, and Natco Pharma submitted an abbreviated new drug application (ANDA) to FDA for its Ibrutinab tablets.

Escalating prices of generic drugs in the US

Generics/Research | Posted 15/03/2019

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on average. Public outcry has led to a flurry of legislative proposals, and two federal bills were introduced in 2017 to improve price transparency and identify drugs exhibiting outlier ‘price spikes’, however, both remain unenacted. In the first three months of 2018, 53 drug pricing transparency bills were initiated in 23 state legislatures.

Pilot procurement scheme in China cuts drug prices

Generics/General | Posted 08/03/2019

The Chinese pharmaceutical market, which is dominated by domestic manufacturers, is the second largest in the world in terms of value after the US. In a bid to lower drug prices for patients and reduce costs for manufacturers, the Chinese State Medical Insurance Administration introduced a national pilot scheme for tendering with minimum procurement quantities in a recent round of reforms across 11 major cities. If proven successful, the scheme is expected to be rolled out across China.

The 700-dollar vitamin: excessive generics prices in the US

Generics/Research | Posted 01/03/2019

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K₁ as an example [1].

USP action plan for generics and FDA new innovation office

Generics/General | Posted 01/03/2019

The US Pharmacopeia (USP) has issued an action plan to promote generics and the US Food and Drug Administration (FDA) has announced the creation of a new office for drug innovation.

Mylan launches Advair generic at 70% discount

Generics/News | Posted 01/03/2019

US-based drugmaker Mylan announced on 12 February 2019 the launch of Wixela Inhub (fluticasone/salmeterol inhalation powder, USP) at a list price 70% less than the originator product, GlaxoSmithKline’s (GSK) best-selling asthma drug Advair Diskus.

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa

Generics/Research | Posted 15/02/2019

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on candesartan and rosuvastatin use in South Africa [1].

Zydus gets FDA approval for skin, heart and acid reflux generics

Generics/News | Posted 15/02/2019

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene^®AF, and generic amlodipine and atorvastatin tablets (Caduet^®). It has also received tentative FDA approval to market generic esomeprazole magnesium delayed-release capsules (Nexium^®). This brings the total approvals of the Zydus group to 247, and it has so far filed over 330 abbreviated new drug applications (ANDAs) since the filing process commenced in the 2003‒2004 financial year.

FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate

Generics/News | Posted 08/02/2019

By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspension, 2.5 mg/mL, and Dr Reddy's Laboratories Ltd (Dr Reddy) launched its sevelamer carbonate for oral suspension.

Generics applications under review by EMA – January 2019

Generics/General | Posted 01/02/2019

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

Generics/News | Posted 01/02/2019

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

Generics/General | Posted 25/01/2019

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

Generics/News | Posted 25/01/2019

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

Generics/Research | Posted 18/01/2019

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

Generics/News | Posted 18/01/2019

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

Generics/News | Posted 11/01/2019

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

Generics/News | Posted 14/12/2018

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

Generics/General | Posted 07/12/2018

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).