European Notebook Notes Arrival Of CHMP Minutes And Biosimilar MAbs

CHMP has released for the first time the minutes of its meeting, and EMA has set up a new pharmacovigilance cluster with the FDA. A biosimilar infliximab product from Hospira and Alvogen has become the first biosimilar monoclonal antibody launched in Europe.

Anyone expecting an explosion of information on the approval process for new medicines following the European Medicines Agency’s decision to publish the agenda and minutes of meetings of its scientific advisory panel, the Committee for Medicinal Products for Human Use (CHMP), for the first time at the end of January was sorely disappointed .

The minutes of the December 2013 CHMP meeting, released on Jan. 28, were big on describing procedures but were short on narrative explanations: “All issues previously identified in this application had been addressed,” was a recurring phrase used in the minutes, leaving the reader at a loss as to what might have been discussed. The minutes also say: “some items in this section are considered commercially confidential or sensitive and therefore not disclosed,” thereby at a stroke removing portions of the discussion from the public gaze.

The publication of the agenda and minutes of CHMP meetings does however give pharmaceutical companies the opportunity to track the progress of potential competing products from rivals through the approval procedure.

Still, EMA is at least sharing information with other regulatory authorities. The agency will join in regular monthly teleconferences on pharmacovigilance with FDA, announced Feb. 19, to strengthen their existing information exchanges in the area. The regulators already have similar discussion forums, called “clusters”, for other topics including biosimilars, oncologics and orphan medicines, all covered by confidentiality agreements. Canadian and Japanese regulators also take part in the clusters as observers.

More from Europe

Other European developments covered over the past month include:

• (Also see "German Pharma Wants Inflation-Linked Deal To Replace Drug Price Freeze" - Pink Sheet, 14 Feb, 2014.)
• (Also see "EU Pharma Denies Skirting Rules On Pediatric Cancer Drug Development" - Pink Sheet, 13 Feb, 2014.)
• (Also see "EU SCOPE Project Will Harmonize Pharmacovigilance, Benefit Industry" - Pink Sheet, 6 Feb, 2014.)
• (Also see "EU Tamper-Evident Packaging Requirement To Cost Generics Firms $700M" - Pink Sheet, 31 Jan, 2014.)

EFPIA’s Commitments

For its part, the European pharmaceutical industry is coming round to being more transparent. In 2014, “we will deliver on our commitments on sharing clinical data more widely, with researchers and the public,” said Richard Bergstrom, director general of the European industry association, EFPIA, in a Jan. 28 webcast conversation with “The Pink Sheet.”

“We also have to deliver on our commitment to be transparent about our relationships with health care professionals,” Bergstrom noted. He said he was also looking forward to something substantial arising out of the trade negotiations between the U.S. and EU, the TTIP (Transatlantic Trade and Investment Partnership) talks, and delivering IMI-2, the industry’s multibillion dollar research collaboration with the European Commission.

2014 is an important year for Europe, with a new parliament and European Commission being set up following elections in May .

EMA Prepares For Advanced Therapies

The year is also shaping up to be significant for gene and cell therapies. EMA’s powerful Committee for Advanced Therapies, which advises the CHMP on whether to recommend approval for gene, cell and regenerative therapies, is expecting three to four new advanced therapy medicinal products (ATMPs) to apply for marketing approval in 2014.

Judging from the number of potential products it has classified as ATMPs over the past several years, CAT’s work is likely to increase in the next few years – the committee classified 12 potential therapies as ATMPs in 2011, 14 in 2012 and 23 in 2013. Later this year, it is organizing a private workshop on cell therapy for cardiac repair to inform the development of scientific and regulatory requirements, and is addressing the thorny problem of how to measure quantitatively the biological activity of a cell-based therapy.

The EU has approved four ATMPs so far – uniQure NV’s Glybera, Dendreon Corp.’s Provenge, and two cultured cartilage cell products, [Genzyme BV] ’s MACI and TiGenix NV’s ChrondoCelect.

Orphans Popular Too

Seeking an ATMP classification is not yet as popular as filing for orphan drug designation – the EU’s Committee for Orphan Medicinal Products received 201 applications for orphan designation during 2013, and gave the designation to 136 products. Eleven orphan medicines achieved a marketing recommendation during 2013, up from eight in 2012 and four in 2011.

The COMP also received 108 requests for scientific advice about how to develop orphan medicines, and two companies with potential orphan medicines received parallel scientific advice about how to develop them from the CHMP, the COMP and health technology assessment bodies, under an EMA program. In 2014, the COMP intends to raise awareness of the need to show a significant benefit in order to obtain 10 years of marketing exclusivity for an orphan medicine. Around half of all applications for orphan drug designation received parallel scientific advice from EMA, the FDA and Japan’s PMDA during 2013.

Europe’s First Biosimilar MAb

Europe’s first biosimilar monoclonal antibody, Hospira Inc.’s Inflectra (infliximab), developed in collaboration with South Korea’s Celltrion Inc., was launched in eight countries in central and eastern Europe in mid-February., following EU Commission approval in September 2013 .

The rapidly growing privately owned U.S. generics company Alvogen Inc. is collaborating with Hospira on the marketing of Inflectra in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland and Romania, under a 2011 agreement – the two companies already market a number of other biosimilars in central and Eastern Europe.

Inflectra will be launched in other European countries when patent protection expires in each one over the next several years – Johnson & Johnson is believed to have patent protection on the branded product, Remicade, in most of Western Europe until February 2015, although expiries could be sooner in smaller markets. In Norway, a non-EU country, Hospira and local marketing partner Orion Pharma have recently won hospital tenders to supply infliximab at a reduced cost compared to the branded product .

Alvogen is led by ex-Actavis CEO Robert Wessman, who is chairman and executive CEO, and has manufacturing facilities in the U.S., Romania and South Korea. The company has signaled its commitment to developing biosimilar monoclonal antibody products by setting up an independent affiliate in Iceland, Alvotech, to manufacture them .

Patent Cliff Affects Ireland’s Economy

Patent expiries can also affect the economies of small European countries. Ireland Minister of Finance Michael Noonan recently noted the country’s exports, although growing, had been affected by the reduced output from the large number of branded manufacturers with facilities located there, whose sales were being eroded because of the emergence of generic competition.

Still, Ireland’s low corporation tax rate and other benefits are still attracting new investment. Alexion Pharmaceuticals Inc. said Feb. 3 it would purchase a vialling facility in Athlone, and Jazz Pharmaceuticals PLC said Feb. 10 it would build its first manufacturing and development facility in Monksland, both in County Roscommon. The tax benefits associated with Dublin-based Actavis acquiring Forest Laboratories have been reported to be one of the drivers of their recently announced merger (Also see "Actavis’ $25 Billion Forest Labs Buy Expands Geographic Reach, Product Portfolio" - Pink Sheet, 18 Feb, 2014.).

Ireland is currently debating whether to introduce universal health insurance in the country, similar to that in other European countries, which would replace the current two-tier system where a public healthcare system and a private insurance market exist side by side, and likely change the payers companies have to deal with.

New Swiss Pricing

Switzerland is another European country that has a vibrant pharmaceutical manufacturing sector, but one where the government is also hoping to rein in health care spending, this time by introducing a new pricing model in 2015 based on an analysis of a drug’s benefits. Switzerland’s pharma market declined by 0.1% in 2013, due to measures introduced over the past two years, including regular pricing reviews of patent-protected products and the promotion of generic prescribing, noted the Association of Pharmaceutical Companies in Switzerland in a recent review.