EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold
Executive Summary
Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.
Coherus BioSciences and Accord Healthcare/Intas are set to become the first companies to break Amgen Inc.’s stronghold of the pegfilgrastim market in Europe.
The European Medicines Agency said today that it was recommending in favor of the European Commission approving biosimilar pegfilgrastim products made by both companies – Coherus’s product is called Udenyca, and Accord Healthcare/Intas’s is Pelgraz.
Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen’s blockbuster bio-originator, Neulasta, said Oliver Spray, an analyst at Informa’s PharmaVitae. Biosimilar versions of Neulasta were also approved for the first time in the US and Canada earlier this year.
The outlook for Neulasta is not necessarily bleak, though. According to Spray, Amgen’s product stands to lose very little from biosimilar approval in Europe, as the majority of the franchise’s sales are in the US. “In 2017, Neulasta generated $3.9bn in the US and just $503m in Europe,” he said.
PharmaVitae expects sales in the five major EU markets (France, Germany, Italy, Spain and the UK) to decrease to $125m by 2022.
“Amgen will also benefit from the expected addition of Neulasta Onpro Kit or On-Body Injector to the Neulasta label,” Spray noted. “This delivery device increases the convenience of administration and could help Neulasta stave off competition from biosimilars which will not be approved as an On-Body Injector.” A decision from the EMA on this addition is expected in Q3 2018.
CHMP Thumbs Up
The biosimilar pegfilgrastim products from Coherus and Accord/Intas received positive opinions in favor of approval from the EMA’s Committee for Medicinal Products for Human Use (CHMP) this week. (Also see "EU First For Pegfilgrastim Biosimilars? EMA Decides This Week" - Pink Sheet, 24 Jul, 2018.) Both products are indicated for use in reducing the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
The CHMP’s opinion will now be forwarded to the commission for a legally binding decision valid throughout the EU. The commission usually follows CHMP recommendations and generally makes its decision within 67 days.
A Significant Milestone For Coherus
According to Coherus, the CHMP’s decision marks “a significant milestone” for the company. “It validates both our Udenyca biosimilarity package as well as our development platform as a whole," Denny Lanfear, company’s president and CEO, said in a statement. "We believe Udenyca will represent an important option for patients, providers and payers seeking alternatives for the treatment and prevention of febrile neutropenia due to cytotoxic chemotherapy in Europe."
Coherus said that Udenyca's marketing authorization application to EMA was supported by analytical similarity data, a three-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamics (PD) study in healthy subjects, as well as a robust immunogenicity package including a dedicated immunogenicity study in over 300 subjects.
The company is expecting a decision from the commission in October. Udenyca is also under evaluation by the US Food and Drug Administration, with an action date expected on or before Nov. 3.
Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5bn in 2017, the Redwood City, California, firm said.
Accord’s Valuable Marketing Experience
As for Pelgraz, Indian company Intas said that its UK-based marketing arm, Accord, had gained “valuable experience” in bringing biosimilar medicines to market, having launched its first European-approved biosimilar product, Accofil (filgrastim), in 2015. Despite being the sixth entrant, Accofil has become a leading supplier of this vital medicine, and has been used over used over two million times, Intas added.
The CHMP's positive opinion was based on Pelgraz's clinical development program, which supported the product’s biosimilarity with Neulasta through a Phase I, randomized, assessor-blinded PK/PD study in healthy volunteers, and a Phase III study of patients with breast cancer (stage IIa, IIb, or IIIa) on TAC (docetaxel, doxorubicin, cyclophosphamide).
Recent Approvals
Neulasta was first approved in the EU in 2002. The EMA is currently reviewing marketing authorization applications for six other biosimilar pegfilgrastim products. Among the companies known to have filed these MAAs are Cinfa Biotech, Sandoz, Mylan/Biocon and USV (India).
Biosimilar pegfilgrastim products only recently started to be approved around the world by more stringent regulatory authorities. Health Canada became the first when it approved Apotex’s Lapelga in April. (Also see "Apotex Bags First Biosimilar Neulasta, Plans To Undercut Amgen In Canada By 25%" - Pink Sheet, 23 May, 2018.) The US Food and drug Administration approved Mylan/Biocon’s Fulphila in June. (Also see "Mylan Is First To Clear US Neulasta Biosimilar Hurdle; At-Risk Launch May Not Be Risky" - Pink Sheet, 5 Jun, 2018.) A number of versions of pegfilgrastim are available on the Indian market, but these are thought to have been approved before formal biosimilar guidelines were put in place there in 2012.
The European generics and biosimilar industry body, Medicines for Europe, has said that data packages supporting the approval of the Indian products were “very unlikely to be EU/US/WHO compliant when it comes to biosimilarity.”