Posts Tagged “biologics”
Dr. Steven Curry, a medical toxicologist and professor at the University of Arizona, has treated snakebites since the 1980s — long enough to remember when the treatment represented its own form of misery. The first medication Curry used sometimes caused an immune reaction called serum sickness — patients broke out in a severe, itchy rash. Then, about 20 years ago, the snake antivenin CroFab entered the market and dramatically reduced the adverse reactions associated with treatment, he says.
But the drug came with a sky-high price tag. In one case reported by NPR and Kaiser Health News , an Indiana hospital last summer charged nearly $68,000 for four vials of CroFab. Now, CroFab faces competition from a snake antivenin called Anavip . Curry says the health system he works for in Phoenix — Banner Health — is using the new drug as its first line of treatment. It is switching, he says, because Anavip could reduce readmissions by better controlling bleeding associated with a snakebite and lead to “substantial savings” for the hospital.
But few experts who study drug laws and drug prices expect this competition to reduce the cost for patients. Legal wrangling, the advantageous use of the…
Members of Congress from both parties served notice on pharmaceutical companies on Tuesday that the days of unchecked drug-price increases were over and that they would be held politically accountable for exorbitant prices.
The new reality became apparent at simultaneous but separate hearings of House and Senate committees where lawmakers said that the relentless increases were unsustainable and unacceptable.
“There is a strong bipartisan consensus that we must do something to rein in out-of-control price increases,” said Representative Elijah E. Cummings, Democrat of Maryland and the chairman of the House Committee on Oversight and Reform. “Drug companies make money hand over fist by raising the prices of their drugs — often without justification and sometimes overnight — while patients are left holding the bill.”
On the other side of the Capitol, Senator Charles E. Grassley, Republican of Iowa and the chairman of the Finance Committee, and Senator Ron Wyden of Oregon, the senior Democrat on the panel, denounced drug company executives who they said had refused to testify voluntarily.
Mr. Grassley expressed “displeasure at the lack of cooperation from the pharmaceutical manufacturers” and vowed to insist on their testimony in coming months.
Mr. Wyden said: “Even the Big Tobacco C.E.O.s…
You have to wonder if key players in the biosimilars industry in the United States don’t feel like Phil Connors, the character played by Bill Murray in the 1993 classic movie Groundhog Day. (Is it safe to call it a classic?) Connors is condemned to relive the same events of February 2 until he transforms from being a jaded, binge-drinking souse to a charitable, conscientious person.
Those observing—and working in—the biosimilars industry might sometimes feel like the unrepentant Connors, waking to Sonny and Cher’s “I Got You Babe” every morning. For more than two decades, biosimilars in this country have been stuck in a repeat mode of potential and promise. Now hopes for breaking out of that loop are clinging to FDA Commissioner Scott Gottlieb and the “Biosimilars Action Plan”—or BAP—he announced last July. The idea is to dismantle the regulatory hurdles that have prevented the American health system from adopting biosimilars and cashing in on the price difference between the copycats and the brand-name medications. The problem is that even if Gottlieb’s BAP were to be fully implemented, there are still all sorts of legal and other obstacles in the way of biosimilars catching on.
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)…
We wrote last week about a major price-cut announcement from a leading U.S. based biotechnology company—a move that fits perfectly with the Trump administration’s agenda of reducing drug prices and particularly lowering out-of-pocket costs to consumers through free-market competition.
But the news that Amgen was cutting the list price by 60% of one of its newest biologics, Repatha, got buried in the avalanche of news coverage about the administration’s own plans to try to use the levers of government control to force the reduction of Medicare prices for many drugs administered by physicians. This feels like an alternative universe. (More on that in a subsequent post.)
Amgen announced it was immediately making Repatha available at a reduced list price of $5,850 a year, down from about $14,500 a year, saying the move “will improve affordability by lowering patient copays, especially for Medicare patients.”
Repatha treats patients who have excessively high levels of cholesterol, including those who do not respond to traditional statins, and who therefore are at a high risk of heart attacks and strokes. It is a new class of PCSK9 inhibitors that dramatically lower cholesterol levels in patients.
By creating new, significantly lower list pricing, patients who pay a share of…
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…
During CIIE 2018, AstraZeneca will present 30 drugs it has brought to China over the past two decades. Chinese patients will be the first to benefit from the innovative medicine.
As the second largest multinational pharmaceutical company in China, AstraZeneca’s innovation will benefit not only Chinese patients but industry partners and the global market.
First coming to China in 1993, AstraZeneca’s sales in China totaled US$2.96 billion in 2017 and China holds an important strategic position in AstraZeneca’s global R&D, operations and commercial innovation.
“AstraZeneca has benefited from opening up and reform and at the same time we have been an active contributor. Our innovative business models will soon be extended to other markets,” said Leon Wang, Executive Vice President, International and China President at AstraZeneca.
In an evolving culture, every company wants to attract and retain the best talent. AstraZeneca is actively adjusting its business strategy in China, and local innovation has been an important step. The aim is to break the boundaries of science and delivering life-changing drugs.
That goal is in everything AstraZeneca does, a reason to go to work every day. It helps bring benefits to Chinese patients and creates value for shareholders. This pioneering business…
The implications of adalimumab’s European patent expiry
The NHS’s bid to improve patient outcomes and save money by switching costly biological drugs for cheaper biosimilars reached a major milestone in October when adalimumab – which has the highest global turnover of any medicine – came off patent in Europe.
The NHS has already achieved savings of £210 million through the use of biosimilar medicines, according to recent figures for 2018/19, and it plans to widen the market further as adalimumab, which is used for a range of conditions, is opened up to competition from cheaper rivals.
Regional Medicines Optimisation Committees (RMOCs), which were launched last year, have been playing a pivotal role in working with NHS commissioners and providers on best value biologics and helping them to prepare for adalimumab’s patent expiry.
The role of RMOCs
NHS England’s Medicines Value programme aims to help improve outcomes whilst keeping medicines affordable. A key strand of the programme involves optimising the use of medicines via the four RMOCs, which are based in London, the south, the north, and in the Midlands and east of England. They are designed to operate as a single, strategic medicines optimisation system for the whole country.
The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, ulcerative colitis and Crohn’s disease — depend on safe and effective biological medicines called tumor necrosis factor (TNF) inhibitors. These are highly effective but can cost as much $48,000 annually for a single patient.
Historically, biologics have enjoyed long market life because there was no approval pathway for biosimilars or follow-on biologics, that are copies of an originator biologic medicine. While not exactly generic copies, biosimilars have the potential to affect the market the same way: by introducing competition and driving down costs, while maintaining safety and efficacy. Congress created such a path in 2010, through the Biologics Price Competition and Innovation Act (BPCIA).
Results to date are mixed. The U.S. Food and Drug Administration (FDA) has approved six TNF inhibitor biosimilars, however, only two TNF inhibitor biosimilars are on the market, and the FDA approval pathway for approving biosimilars as “interchangeable” has not been finalized. Biosimilars are lowering the price of biologics in the US, being priced 35 percent lower than the originator biologic. Yet, well after FDA approval, they only represent six percent of the market. If instead they…
The World Health Organization (WHO) has published a new report on reimbursement policies in Europe that provides a comparative review and analysis of the policies employed by 45 different European countries, and says that promoting the uptake of lower-priced medicines such as generics and biosimilars will “facilitate efficiency gains without disadvantaging patients.”
In most of the countries studied, WHO found that generic substitution is practiced at the pharmacy level; in 29 countries, substitution of a cheaper generic by a pharmacist is allowed and the practice is mandated. in 12 countries. Only 4 countries—Austria, Bulgaria, Luxembourg, and the United Kingdom—do not permit a pharmacist to substitute a cheaper generic. Some countries even give financial incentives to pharmacists to make substitutions; in Switzerland, pharmacists receive a fee for doing so.
In many cases, patients can still receive a more expensive brand-name drug without a doctor’s written justification, though they may pay more in out-of-pocket costs if they refuse a generic.
One measure that has allowed for greater generic uptake, says the report, is prescribing medicines by international nonproprietary name (INN) rather than by brand name, allowing pharmacists to dispense the lowest-cost option with the same active ingredient. INN prescribing is allowed in…