London, UK: The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, issued its opinion related to approval of the following drug candidates on Friday. Once a CHMP opinion is announced, it takes 67 days for the European Commission to announce its decision.
Coherus BioSciences Inc. (CHRS)
Coherus BioSciences’ UDENYCA, a biosimilar candidate of Amgen’s (AMGN) blockbuster Neulasta, for treating side effects from chemotherapy, received a positive opinion from the CHMP.
The European Commission decision on the approval for UDENYCA is expected in October. If approved, UDENYCA has the opportunity to become one of the first Neulasta biosimilars to gain Marketing Authorization in Europe.
UDENYCA is also under FDA review, with a decision expected on or before November 3, 2018.
The US patent on Neulasta expired in October 2015 and the European patent in August 2017. Neulasta had worldwide sales of over $4.5 billion in 2017.
In the U.S., the first biosimilar to Neulasta was approved in June 2018, and it is Mylan’s Fulphila.
CHRS closed Friday’s trading at $17.60, down 4.09%.
Vertex Pharmaceuticals Inc. (VRTX)
The CHMP has adopted a positive opinion recommending approval of Vertex Pharma’s SYMKEVI in a combination regimen with KALYDECO for the treatment of people with cystic fibrosis aged 12 and older with certain mutations in cystic fibrosis transmembrane conductance regulator (CFTR) gene.
SYMKEVI in combination with KALYDECO now awaits the European Commission decision.
In the U.S., SYMKEVI is marketed under the brand name SYMDEKO, and SYMDEKO in combination with KALYDECO was approved by the FDA in February 2018.
Since its launch through June 30, 2018, SYMDEKO has generated net product revenue of $220 million.
VRTX closed Friday’s trading at $172.10, down 2.14%.
Mylan N.V. (MYL)
The CHMP has adopted a positive opinion recommending approval of Mylan and Fujifilm Kyowa Kirin Biologics’ Hulio, a biosimilar candidate of mega blockbuster drug Humira.
The decision of the European Commission (EC) on the approval of Hulio is expected in October 2018, which would grant marketing authorization in the 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.
Hulio is recommended for all the indications for which Humira is prescribed namely, Rheumatoid arthritis, Ankylosing spondylitis, Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, Psoriatic arthritis, Psoriasis, Hidradenitis suppurativa, Crohn’s disease, Ulcerative colitis and Uveitis in adults, and for the treatment of pediatric inflammatory diseases, including polyarticular juvenile idiopathic arthritis (age 2 and older), enthesitis-related arthritis (age 6 and older), plaque psoriasis (age 4 and older), Crohn’s disease (age 6 and older), hidradenitis suppurativa (age 12 and older) and uveitis (age 2 and older).
Humira, developed by AbbVie (ABBV), had global sales of $18.4 billion in 2017.
The first Humira biosimilar to be approved in Europe is Amgen’s Amgevita, which was greenlighted in March 2017, followed by Samsung Bioepis’ Imraldi in August 2017, Boehringer Cyltezo in November 2017, and Novartis’ Hyrimoz in July 2018. The biosimilar versions of Humira are expected to be launched in Europe in October of this year.
However, in the U.S., although the biosimilar versions of Humira have been approved, they are not going to be launched till 2023.
In the U.S. too, Amgen’s Amgevita, which won FDA approval in September 2016, is the first Humira biosimilar to be have been approved. Boehringer Ingelheim’s Cyltezo, approved by the FDA in August 2017, is another biosimilar for Humira in the U.S.
Novartis has sought FDA approval for its version of Humira, and a filing was made in January of this year.
MYL closed Friday’s trading at $36.22, up 0.33%.
Genmab A/S (GMXAY.OB)
The CHMP has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX in the European Union. The recommendation is for the use of DARZALEX in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
A final decision by the European Commission is anticipated within approximately two months.
In the U.S., the above mentioned combination regimen of DARZALEX was approved by the FDA in May 2018.
DARZALEX was granted conditional approval in May 2016 as a standalone therapy for treatment of adult patients with relapsed and refractory multiple myeloma. The following year, i.e., in April 2017, the European Commission granted approval for DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone in patients who have received at least one prior therapy.
In August 2012, Genmab granted Johnson & Johnson’s Janssen Biotech, Inc., an exclusive worldwide license to develop, manufacture and commercialize DARZALEX. Genmab receives royalties on the worldwide net sales of DARZALEX under the license agreement.
The worldwide net sales of DARZALEX as reported by Johnson & Johnson were $1.24 billion in 2017.
GMXAY.OB closed Friday’s trading at $17.80, down 0.89%.
Array BioPharma Inc. (ARRY)
The CHMP has adopted a positive opinion recommending approval of Array BioPharma’s BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation.
The final decision of the European Commission is expected by the end of September, and it will be applicable to all 28 EU member states, as well as Liechtenstein, Iceland and Norway.
In the U.S., BRAFTOVI in combination with MEKTOVI was approved by the FDA for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test in June of this year.
BRAFTOVI + MEKTOVI are available to order through select specialty pharmacies in the U.S. market.
ARRY closed Friday’s trading at $15.08, down 7.71%.
Tetraphase Pharmaceuticals Inc. (TTPH)
Tetraphase Pharma’s Xerava has been recommended for approval by the CHMP as a treatment for adult patients with complicated intra-abdominal infections (cIAI).
The CHMP’s opinion will be reviewed by the European Commission, or EC, which is expected to make a final decision within three months. If approved by the EC, marketing authorization for Xerava will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.
Xerava is also under FDA review, with a decision expected on August 28, 2018.
TTPH closed Friday’s trading at $2.85, up 2.15%.
Alnylam Pharmaceuticals Inc. (ALNY)
The CHMP has adopted a positive opinion recommending approval of Alnylam Pharma’s Patisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy.
If approved by the European Commission, Patisiran will be commercialized under the brand name ONPATTRO.
In the U.S., Patisiran is currently under priority review by the FDA, with a decision expected on August 11, 2018.
ALNY closed Friday’s trading at $104.51, down 1.91%.
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
EMA serves a market of over 500 million people living in the EU.