The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended six new-medicine approvals (including two orphan drugs). The CHMP additionally issued positive recommendations for the therapeutic-indication extension of three medicines.
IHS Life Sciences perspective | |
Implications | The November meeting of the CHMP issued six recommendations for new-medicine approvals in the European Union, as well as three recommendations for indication extensions. |
Outlook | Final market-authorisation approval is expected to be granted by the European Commission in the first quarter 2016. Market authorisation by the European Commission will enable the commercialisation of medicines in all EU member states, as well as Iceland, Liechtenstein, and Norway. |
On 20 November, the European Medicine Agency (EMA)'s Committee for Medicinal Product for Human Use (CHMP) recommended the approval of six new medicines and three generics. Additionally, the CHMP issued three recommendations for indication extensions. The full text is available to view here.
Positive recommendations for new medicines | |||
Drug | Company | Therapeutic indication | EMA notes |
Benepali (etanercept; 50 mg solution for injection) | Samsung Bioepis (joint venture between Samsung and Biogen) | Treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis | Biosimilar version of Enbrel (etanercept; Amgen, Pfizer US) |
Broviac (brivaracetum) | UCB (Belgium) | Epilepsy patients (aged 16 and older) with uncontrolled partial-onset seizures | Phase III studies (N01252, N01253 and N01358) demonstrated statistically significant reduction over placebo in partial-onset seizure frequency per 28 days |
Episalvan (birch bark extract) | Birken AG (Germany) | Treatment of partial thickness wounds | Gel for cutaneous use reduces healing time of wounds where the upper layers of skin have been damaged |
Oncaspar (pegaspargase) | Baxalta (US) | Treatment of acute lymphoblastic leukaemia (ALL) | Authorised in Poland (2008) for patients with ALL who were hyper-sensitive to native forms of asparaginase |
Spectrila (asparaginase) | Medac GmbH (Germany) | Indicated as part of anti-neoplastic combination therapy for ALL in paediatric patients (ages 0-18 years) and adults | Designated an orphan medicine in January 2005 |
Wakix (pitolisant) | Bioprojet Pharma (France) | Treatment of narcolepsy with or without cataplexy (such as sudden severe muscle weakness or loss of muscle control) | First-in-class; designated orphan medicine July 2007 |
Positive recommendation of generic medicines | |||
Drug | Company | Therapeutic indication | Characteristics |
Eptifibatide Accord (eptifibatide) | Accord Healthcare (UK) | Prevention of early myocardial infarction in adults with unstable angina or non-Q-wave myocardial infarction | Generic version of Integrilin (Merck, US) |
Pemetrexed Accord (pemetrexed) | Accord Healthcare (UK) | Treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic NSCLC | Generic version of Alimta (Eli Lily, US) |
Lopinavir / ritonavir Mylan (lopinavir + ritonavir) | Mylan (Netherlands) | In combination with other anti-retroviral medicinal products for the treatment of HIV in adult, adolescent, and pediatric patients (2+) | Generic version of Kaletra (AbbVie, Abbott, US) |
Positive recommendation for hybrid medicine | |||
Drug | Company | Therapeutic indication | Characteristics |
Pemetrexed Actavis (pemetrexed) | Actavis (US) | Treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic NSCLC | Generic version of Alimta (Eli Lily, US) |
Negative recommendation for new medicine | |||
Drug | Company | Therapeutic indication | Characteristics |
Solumarv (human insulin) | Marvel Life Sciences (UK) | Intended for the treatment of type 1 and type 2 diabetes | Attempted biosimilar version of Humulin S |
Approval for biosimilar version of anti-inflammatory medicine Enbrel
The most significant recommendation was for Samsung Bioepis (UK)'s biosimilar version of the blockbuster tumour necrosis-factor (TNF) inhibitor Enbrel (etanercept; Amgen, US) for the treatment of several autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, and plaque psoriasis. Assuming the drug secures subsequent approval for commericalisation from the European Commission (which it is virtually certain to do), Benepali will become the first biosimilar version of Enbrel marketed in Europe. Enbrel lost patent exclusivity in Europe in February 2015, thereby opening market opportunities for biosimilar manufacturers. The biosimilar challenger will be marketed in Europe by Biogen (US), and will be produced at manufacturing facilities located in Denmark. The launch of the biosimilar will threaten sales of Amgen's Enbrel in Europe, and is likely to result in immediate intensive price-competition in the anti-inflammatory market segment. AbbVie (US)'s rheumatoid arthritis drug Humira (adalimumab) is also considered at risk from Benepali.
The precedent of biosimilar versions of monoclonal antibody Remicade (infliximab) resulted in price discounts reaching as high as 69% (although averaging 45% overall) compared with the reference drug. Since its launch, biosimilar copies of infliximab have also shown large increases in market share to the point of achieving market dominance in a handful of European countries (see Norway: 18 October 2015: Biosimilar Remsima set to achieve market dominance in Norway according to NOMA). A similar situation is likely to occur with the biosimilar version of Enbrel. Biogen and Samsung (South Korea) have not given any indication regarding the possible price discounts the firms are prepared to offer European healthcare systems; however an initial strategy of a 20–30% discount to Enbrel is likely. Samsung Bioepis is planning to launch in early 2016, and may aim at launches in the Nordic countries first.
The approval of the biosimilar challenger was based on head-to-head Phase III clinical trial data comparing Benepali with reference drug Enbrel. The 52-week, multi-centre, double-blind study involved 596 patients with moderate-to-severe rheumatoid arthritis. Patients receiving Benepali showed an ACR20 response rate of 80.8%, versus 81.5% for patients administered with the originator Enbrel.
Positive recommendation for extension of therapeutic use | ||
Drug | Company | Therapeutic indication |
Cimzia (certolizumab pegol) | UCB (Belgium) | Treatment of severe, active and progressive rheumatoid arthritis in DMARD-naïve adult patients |
Pyramax (pyronaridine + artesunate) | Shin Poong Pharmaceutical (South Korea) | Extension of indication covering repeated courses of treatment in patients and on its use only in areas of low malaria transmission with evidence of artemisinin resistance |
Zutectra (human hepatitis B immunoglobulin) | Biotest AG (Germany) | Prevention of HBV re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation |
Outlook and implications
The recommendations issued at the EMA's CHMP November meeting are expected to be approved by the European Commission within three months of the publication of the CHMP opinion. The subsequent European Commission decision will be applicable to all 28 EU countries in addition to Norway, Iceland, and Liechtenstein. Among the other position opinions which the CHMP delivered was a recommendation to grant market authorisation for the first-in-class drug Wakix (pitolisant; Bioproject, France) as a treatment option for narcolepsy. The recommendation requires Bioprojet to conduct long-term safety studies for Wakix. However, Bioprojet will nonetheless benefit from 10 years' market exclusivity, having secured an orphan-drug designation for Wakix from the European Union (dating to 2007). Elsewhere, the CHMP also issued one negative opinion on a new biosimilar Solumarv (human insulin; Marvel Life Sciences).
A further significant recommendation issued by the CHMP was that of UCB (Belgium)'s Briviact (brivaracetam) for the treatment of partial-onset seizures in patients with epilepsy aged 16 years and older. The approval was based on Phase III data which showed that 38.9% (98/252) of patients reported a 50% or greater reduction in partial-onset seizures with Briviact 100 mg/day, and 37.8% (94/249) for brivaracetam 200 mg/day, compared with 21.6% (56/259) for a placebo (p<0.001 for both dose arms; see Belgium: 9 December 2014: UCB presents Phase III study results on brivaracetam for uncontrolled partial-onset seizures). The recommendation is expected to boost UCB's sales, and strengthen its epilepsy portfolio in Europe.