Posts Tagged “Biogen”

Will big pharma exit the biosimilar market when margins start dropping?

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Will big pharma exit the biosimilar market when margins start dropping?

As prices drop, Big Pharma will exit the biosimilar space over the next five to 10 years, says industry expert Sarfaraz Niazi. Amgen, Novartis and Pfizer refute the claim, saying they are in the sector for the long-term.

Blockbuster biologic originator companies are, by definition, Big Pharma firms and the target of biosimilar developers. Roche and AbbVie, two of the firms most susceptible to biosimilar erosion, have vocalized the need for a stringent regulatory framework – including calls for appropriate data, individualized labels, and unique identification for all biotherapeutics – while attempting to bat off competition by reformulating products and beefing up both their pipelines and IP.

But at the other end of the Big Pharma spectrum, there are several firms that dominate the biosimilar European and US markets, namely Novartis, Pfizer and Amgen, which all claim to have some of the largest biosimilar pipelines in the industry.

Novartis – through its Sandoz division – has been marketing biosimilars for over a decade in Europe, and was the first to launch a biosimilar in the US after Zarxio, its version of Neupogen (filgrastim), received approval in 2015.

Pfizer, which was the first to launch a version of J&J’s Remicade (infliximab)…

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IPHA in Ireland finds it challenging establishing partnerships with key stakeholders and authorities

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IPHA in Ireland finds it challenging establishing partnerships with key stakeholders and authorities

Big Pharma in Ireland has an image problem. At least that’s how it sees it. “I think we are not seen as a trusted partner,” says Aidan Lynch, president of the Irish Pharmaceutical Healthcare Association (Ipha), the body representing the research pharma industry in Ireland. Partnership is a recurring theme for Lynch as he starts his two-year term as head of the group that has spent much of its recent past at loggerheads with government and the health authorities over getting its members paid for the new medicines they develop.

“I want to move us along in terms of how the other side, if I can say that, sees us in terms of partnership,” he says. “I think as a representative body we’re not anywhere close to where we should be in terms of how our stakeholders see us in terms of partnership.”

Little surprise then that the term “partnership” figures prominently in the lobby group’s recent policy document which carries the somewhat grandiose title of Manifesto for Better Health.

Lynch acknowledges that too often the conversation between the parties has been about price rather than the wider benefit of new therapies.

“The perception from the other side is that…

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The European Drug Pricing Dilemma Lurches Forwards

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The European Drug Pricing Dilemma Lurches Forwards

July has seen one very positive development in the faltering attempts by Europe’s governments to resolve that challenge of providing patients with innovative medicines without bankrupting health budgets. A joint decision on reimbursement was reached by two European countries on an expensive new drug—very much a first for a continent divided by dozens of distinct national pricing authorities.

Belgium and the Netherlands reached an agreement with Biogen on the pricing and reimbursement of Spinraza, the company’s nusinuren, indicated for 5q spinal muscular atrophy at a list price of close on $1 million per patient. After three years of cooperative efforts aimed at conducting joint negotiations with drug companies, they have at last got a result. Negotiations began in February, and involved a joint health technology assessment as well as three-way talks between Biogen and the Belgian and Dutch health ministries. Spinraza will be reimbursed for specific groups of patients in both countries under similar conditions, and at price that both countries characterized as “acceptable”—although neither revealed just what the agreed price was.

Belgian health minister Maggie de Block was quick to hail the achievement as a watershed moment for Europe—”a giant step forward”.  So too was her Dutch counterpart, Bruno…

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Co-Pay Tactic by Benefit Managers Credited with Cutting Prescription Drug Prices

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Co-Pay Tactic by Benefit Managers Credited with Cutting Prescription Drug Prices

A recently adopted tactic by U.S. health plans to limit the financial assistance drugmakers provide directly to consumers for prescription medicines is taking a toll on drug prices, according to a new analysis.

Real U.S. drug prices, including discounts and rebates, fell 5.6 percent in the first quarter of this year, compared to a 1.7 percent drop in the same period a year ago, according to Sector & Sovereign research analyst Richard Evans.

He attributed most of the decline to “co-pay accumulator” programs introduced by pharmacy benefits managers, who manage prescription drug benefits and negotiate on behalf of insurers and other payers.

If drugmakers cannot find a way to circumvent these programs by next year, Evans said, those declines could double or triple.

As the cost of medications reaches new heights in the United States, drugmakers have increasingly offered so-called “co-pay assistance” cards, similar to a debit card, that consumers can use at the pharmacy counter to reduce their out-of-pocket costs.

But pharmacy benefits managers such as Express Scripts Holding Co. and CVS Health say these payments insulate consumers from the real costs of their drugs and can push them towards more expensive medications when a cheaper option is available.

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In The Heart Of Biotech, Leaders Explain The Boston Area’s ‘BioBoom’

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In The Heart Of Biotech, Leaders Explain The Boston Area’s ‘BioBoom’

The intersection of Ames and Main streets in Cambridge’s Kendall Square is perhaps the best place to stand if you want to see the biotech industry boom that has overtaken this region since the turn of the century.

Little more than a decade ago, there was only a Legal Sea Foods facing an old chocolate factory-turned-cancer research center.

Today, the sound of construction comes from several directions, and newish buildings are everywhere.

Two buildings attest to the more than $2 billion the Broad Institute of MIT and Harvard has raised from grants, industry and donations to further genetic research. Across Main Street, the Koch Institute for Integrative Cancer Research links cancer biologists with engineers and doctors. Computer science research is housed at the end of the block, with brain science just beyond.

A bit farther away sit even newer drug company buildings, where researchers work on treatments for cancer, inflammatory bowel disease and diabetes, among many other conditions.

There is no place else “in the entire known universe that has this concentration of people interested in the biological and biomedical sciences,” said Eric Lander, founding director of the Broad Institute, with characteristic enthusiasm. “If you draw a circle about two miles around this street corner,…

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Price pressure keeps nine new drugs from Irish patients

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Price pressure keeps nine new drugs from Irish patients

Irish patients are being denied access to nine drugs that are widely available across Europe, largely on cost grounds.

The drugs – most of them cancer therapies – have gone through the Health Technology Assessment, which examines the clinical effectiveness and safety of new drugs as well as their cost-effectiveness and budget impact.

However, they are still not approved for patients by the HSE. On average, the nine drugs have been waiting for two years on a decision from the HSE as to whether it will pay for them, an industry group says.

The therapies are listed on a new quarterly monitor issued by the Irish Pharmaceutical Healthcare Association (Ipha), which represents pharmaceutical manufacturers.

It reports on drugs that are stuck in the system and also those that have been approved. This initial report says that seven new therapies have been approved by the State so far this year. They include MSD’s cancer drug Keytruda and GlaxoSmithKline’s Nucala, which treats severe asthma.

Among the drugs still waiting for approval are Pfizer’s breast cancer drug ibrance and Spinraza, a Biogen drug for the rare genetic disease, spinal muscular atrophy.

Apart from Spinraza, six of the drugs on the list are cancer…

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Patient advocacy groups take in millions from drugmakers. Is there a payback?

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Patient advocacy groups take in millions from drugmakers. Is there a payback?

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more…

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‘Unethical’ Dutch health insurers invest in expensive pharma firms

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‘Unethical’ Dutch health insurers invest in expensive pharma firms

Dutch health insurance companies are investing millions of euros in pharmaceutical companies which charge extremely high prices for their drugs, the Volkskrant reported on Wednesday.

The total investment may only be a fraction of their total invested assets of €15bn, but it does mean there is a conflict of interest with their main function – keeping healthcare costs as low as possible – the paper said.

Last year, for example, CZ invested €1.6m in Biogen, Vertex and Gilead, three firms which have been criticised for their high prices and refusing to justify the cost. Menzis had €1.2m in Biogen while Zilveren Kruis invested in Biogen and Gilead, the paper said.

Biogen, which booked profit of €3.7bn last year, makes a drug to combat the muscle disease SMA, which costs hundreds of thousands of euros a year per patient, the paper said.

VGZ also had investments in the controversial companies but recently sold its shares following criticism from the Dutch healthcare institute.

The institute, which makes recommendations to the government about what the basic health insurance package should include, said last month that insurance companies were acting unethically.

‘You cannot sell this [to the public],’ Utrecht University professor Toine Pieters told…

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Elephants can’t jump? IDEA’s Mike Rea says some Big Pharma players are crushing old beliefs

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Elephants can’t jump? IDEA’s Mike Rea says some Big Pharma players are crushing old beliefs

This is an industry that typically says ‘innovation’ when what it means is ‘invention.’ Innovation, as most purists will argue, is about return on invention, an ability to derive value from pipeline. That is what our Pharmaceutical Innovation Index measures — a company’s ability to launch successfully, to add more value to pipeline molecules than another company would. It is objective, and about how well the past 5 years have gone, regardless of how well the story has been spun.

This year took us by surprise. The idea that ‘elephants can’t jump’ may well be true biologically, but it has been misapplied to large pharma, it seems. Where the trend had been towards smaller, more ‘agile’ companies in previous indices, this year the three fastest risers were AstraZeneca, Novartis and Pfizer. This should give us all pause — if the natural disruption’ of the dinosaurs was self-evident, we’d be seeing it. Instead, they are fighting back, using their scale, combined with wit, to take on the more buzzworthy new guys.

The PII ranks companies by their ability to bring products from Phase I/II to market and commercialize them successfully, and utilizes a range of clinical, regulatory and commercial metrics to do…

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FDA wants to help unproductive drugmakers

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FDA wants to help unproductive drugmakers

SCOTT GOTTLIEB, the thoughtful head of America’s Food and Drug Administration (FDA), has had a busy first year. He has launched the process of lowering nicotine levels in cigarettes, approved self-testing kits for breast-cancer genes and waved through the most new medicines in two decades, as well as a record number of copycat drugs. There is one thing he and his regulatory agency are doing less of, however—regulating. New rules were at a 20-year low in 2017, according to analysts at PwC, a consultancy. Instead, the FDA is providing more guidance to industry. This approach, Mr Gottlieb hopes, will help pharmaceutical firms in America develop drugs more efficiently. Since that is where most drug development happens, the FDA’s philosophy matters beyond American borders.

Given the rapid pace of scientific advances in medicine, you might think Big Pharma is in rude health. You would be wrong. Last year consultants at Deloitte estimated that returns on investment among the biggest American drugmakers fell to 3.2%, from 10.1% in 2010 (see chart). Many observers blame the rising cost of bringing new drugs to market.

It now costs an average of $2bn to develop a new drug, up from $1.2bn in 2010. One theory…

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