The Center for Biosimilars Staff

A small, yet rapidly growing segment of commercially insured US patients have drug costs of more than $250,000 each year, and this group could account for 15% of all drug expenditures in the next 5 years.

Those findings come from a new Prime Therapeutics LLC 

 that analyzed more than 17 million commercially insured members who had at least 1 month of eligibility in 2016 to 2018. In total, 4869 patients were what Prime calls “super spenders,” or patients with claims totaling more than $250,000 annually.

While the patients who fall into this category are relatively few in number, Prime says the group grew by 63% from 2016, and their spending resulted in $800 million in added drug costs, which were defined as the plan plus member cost share after network discounts (rebates and coupons were not included). The number of patients whose costs were more than $750,000 each year also increased by 38%.

In part, emerging treatments for rare diseases have led to these increases in spending. Patients with inherited single-gene disorders accounted for 31%—or $243 million&mdash;of the total increase, with the greatest increases observed for patients with hemophilia, cystic fibrosis, and hereditary angioedema.

Cancer therapies also accounted for a substantial amount of spending (48% or $378 million), with drugs that target breast cancer, multiple myeloma, and lung cancers among the top categories of spending.

Remaining spending largely comprised biologics, including 

 and the rare disease drug eculizumab, which has biosimilar contenders 

, as well as treatments for pulmonary hypertension and multiple sclerosis.

“With continued growth in treatments for rare diseases, including one-time treatments that may carry million-dollar price tags, it’s very likely that health care cost will become even more skewed, with a smaller and smaller fraction of insured members accounting for a larger and larger portion of the total health care cost,” Jonathan Gavras, MD, senior vice president, chief medical officer at Prime, said in a statement. “We must work to ensure drug and gene therapies are priced appropriately to the value they provide, obtained and billed via the cost-effective channel with the highest quality patient management, and value-based contracts are in place to recoup costs if the drug or gene therapy does not maintain effectiveness.”

According to Prime, management of high costs will include utilization management strategies, as well as “proactive conversations with providers and members regarding opportunities to optimize care and the benefit design.”

Bowen K, Gleason PP. Drug super spenders: 2016 to 2018 growth in number of members and total pharmacy plus medical benefit drug cost for members with extremely high annual drug cost in a 17 million member commercially insured population. Presented at: AMCP Nexus 2019; October 29 to November 1, 2019; National Harbor, Maryland.

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Prime Therapeutics Study Shows Growth in Number of Drug "Super Spenders"

Last week, Nevada told 21 diabetes drug manufacturers the state wants $17.4 million in penalties for noncompliance with a new price 

According to press reports, the state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.

Thirteen companies were assessed $910,000, followed by Daiichi Sankyo, which was assessed a $735,000, which was the smallest penalty.

According to a state drug transparency report released earlier this year, about 12.6% of adults in Nevada have diabetes, and 1 in 4 don’t know that they have the disease. Direct and indirect diabetes related expenses cost $2.7 billion in the state.

The transparency law requires that manufacturers divulge justifications for price increases; the most cited reason research and development investments, followed by claims that the drug has more competitive value, changes in marketplace dynamics, rebates provided to pharmacy benefit managers (PBMs), insurers, and others, and manufacturing investments.

The Nevada law requires that PBM managers report rebates in aggregate (but not for individual drugs).

recent study said these laws are largely ineffective

 at revealing true transaction prices for drugs, though policy makers have hailed these legislative solutions as steps toward bringing down the high cost of drugs for US patients. The laws do not require the release of real price information, including discounts and rebates, by all players in the supply chain.

The Nevada Independent, a nonprofit news organization, 

 that the companies have 30 days to either pay the fines in full or 10 days to request an informal dispute resolution meeting with the state. If the companies don’t respond at all, the department will refer the cases to the attorney general’s office to seek a court order to collect the penalty.

The state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.

Nevada Tells 21 Diabetes Drug Makers They Owe $17.4 Million for Violating Transparency Law

Biosimilar developer Celltrion and Juno Pharmaceuticals 

 that they have entered into a comarketing partnership for Celltrion’s trastuzumab biosimilar, Herzuma, and its rituximab biosimilar, Truxima, in the Australian market.

Under the agreement, Celltrion will distribute the products in the Australian market, and Juno, a hospital supplier, will provide sales promotion and hospital contracting services to Australian hospital customers.

The new partnership comes shortly after Celltrion established its Australian branch in Sydney and subsequently joined Australia’s Generic and Biosimilar Medicines Association (GMBA), a group that represents generic and biosimilar manufacturers, suppliers, and exporters.

“At Celltrion Healthcare, our aim is to provide the best possible treatment options for patients and healthcare providers, and by connecting with the GBMA, we look forward to engaging positively to support the uptake of biosimilar medicines in Australia as a way to alleviate pressure on its national health system,” said Hyoung-Ki Kim, vice chairman and chief executive officer at Celltrion Healthcare, in a 

 announcing the company’s new membership in the group.

 in providing education on biosimilars to stakeholders; in May of 2019, the group launched a new educational portal, funded by a grant by the Australian government, that provides tailored education to patients, prescribers, and pharmacists. Included in these materials is information on how some biosimilars—those that are “a-flagged”&mdash;can be substituted for their reference products at the point of dispensing.

Outside of Australia, Celltrion has been engaging in multiple other partnerships; in July of 2019, the company forged a joint 

, Vcell Healthcare Limited, together with Nan Fung Group to commercialize biosimilars in China. Last month, Celltrion also 

 that it will contract with Swiss biologics maker Lonza to manufacture biosimilar infliximab CT-P13, sold as Remsima and Inflectra, in Singapore.

Biosimilar developer Celltrion and Juno Pharmaceuticals announced that they have entered into a comarketing partnership for Celltrion’s trastuzumab biosimilar, Herzuma, and its rituximab biosimilar, Truxima, in the Australian market.

Eye on Pharma: Celltrion and Juno Team Up to Market Biosimilars in Australia

President Donald Trump has signed an executive order on improving Medicare.

Speaking at the retirement center The Villages in Sumpter County, Florida, Trump said on Thursday that the order, titled “Protecting and Improving Medicare for Our Nation’s Seniors,” delivers on his campaign promise to defend the Medicare program.

“I made you a sacred pledge that I would strengthen, defend Medicare,” said Trump, and suggested that he was making good on his promise by signing “a very historic executive order” to ensure that Medicare “will never be taken away from you. We’re not letting anyone get close.”

 itself claims that Democrats’ proposals to institute a “Medicare for All” system, which Trump called a “threat like never before,” would strip seniors of their choices and harm beneficiaries. “Instead of ending the current Medicare program and eliminating health choices for all Americans, my Administration will continue to protect and improve Medicare by building on those aspects of the program that work well, including the market-based approaches in the current system,” the order reads.

To achieve those goals, within 1 year, HHS will propose a regulation that will make it easier to obtain Medicare Medical Savings Accounts and include a payment model that adjusts Medicare Advantage (MA) benefits to allow beneficiaries to share in savings from the program through rebates. HHS Secretary Alex Azar will be required to outline an approach to changing Medicare fee-for-service (FFS) payments to more closely align with prices paid in MA, to propose regulation to give beneficiaries more access to providers and plans, and to propose regulations that will reduce burdens on providers and ensure appropriate reimbursement.

The order also calls for providing seniors with more information about healthcare quality and cost, eliminating waste and combatting fraud, and transitioning toward “true market-based pricing” in the FFS Medicare program, which will involve shared savings and competitive bidding.

In his remarks, Trump said that his administration is “lowering the cost of prescription drugs, taking on the pharmaceutical companies,” yet notably, the executive order did not include a provision to implement the administration’s proposed international price index (IPI) to reduce drug costs in Medicare.

In 2018, the administration released a plan to allow CMS to set prices for some drugs, including biologics and biosimilars, using prices paid in other countries as external references. While some stakeholders voiced 

 about the IPI model, the proposal did garner rare bipartisan interest, and in her own plan to lower drug prices for Medicare, House Speaker Nancy Pelosi, D-California, 

 a similar model that would cap drugs’ prices at 1.2 times the average selling price in Australia, Canada, France, Germany, Japan, and the United Kingdom. Also included in Pelosi’s plan is authorizing HHS to negotiate prices for up to 250 drugs that lack genereic or biosimilar competition.

President Donald Trump has signed an executive order on improving Medicare.
 

Trump Signs Executive Order on Medicare, but No Movement on International Price Index Yet

Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)&mdash;for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

The interleukin-17 (IL-17) inhibitor is already approved to treat ankylosing spondylitis, 

The ongoing PREVENT trial, a 2-year, randomized, double-blind, placebo-controlled study, enrolled 555 patients with nr-axSpA, and the primary end point was Assessment in SpondyloArthritis International Society criteria for 40% improvement (ASAS40) at weeks 16 and 52.

Patients in this study had been taking at least 2 different nonsteroidal anti-inflammatory agents previously, and some patients had received an anti—tumor necrosis factor (anti-TNF) drug in the past. Patients were randomized to receive 150 mg of secukinumab subcutaneously once per month after 4 weekly induction doses, 150 mg of secukinumab subcutaneously once per month without a loading dose, or placebo. In addition to meeting its primary end point, the trial showed a clinically meaningful reduction in disease activity versus placebo, said the drug maker.

“Non-radiographic axial spondyloarthritis is a chronic debilitating disease, which left untreated can have a significant impact on patients’ quality of life,” said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health and Science University, and an investigator in the trial, in a statement. “These positive results indicate a potential new treatment option to help patients experience relief from the signs and symptoms of their disease.”

Novartis has already sought an indication in nr-axSpA in the European Union after having submitted 16-week data to the European Medicines Agency for consideration. Those data, which the drug maker said will be presented at a future scientific congress, show that the trial met its primary end point ASAS40 at week 16.

If secukinumab succeeds in gaining an indication for nr-axSpA, it could compete for an increased share of the inflammatory disease market against an increasing number of US and EU biosimilars, including the recent influx of biosimilar anti-TNF options in the European Union.

It could also see a boost from recent changes to treatment guidelines; in the most recent update to the American College of Rheumatology, the Spondylitis Association of America, and the Spondyloarthritis Research and Treatment Network’s 

 for axial spondyloarthritis, although anti-TNF options are recommended over secukinumab, the guideline recommends treatment with an IL-17 inhibitor among patients who have primary nonresponse to a first anti-TNF agent rather than cycling to other anti-TNFs.

Drug maker Novartis announced that it will seek a fourth indication&mdash;nonradiographic axial spondyloarthritis (nr-axSpA)&mdash;for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

Novartis to Seek a Fourth Indication for Secukinumab

With the US Congress back from its summer recess, September marked a busy time on Capitol Hill for policy proposals that touch on drug pricing, biosimilars, and patient access to high-cost therapies.

First, a group of more than 20 groups, representing patients, employers, and others, in a letter addressed to HHS Secretary Alex Azar, 

asked HHS to end cost sharing for Medicare Part B

 patients when a provider administers a biosimilar rather than a reference biologic. In order to develop the US market, incentives must align, claims the group, and out-of-pocket savings in Medicare Part B could influence the rest of the payer market, as many commercial payers take their cues from CMS payment policies. Signatories included the American Cancer Society Cancer Action Network, the Association of Community Cancer Centers, Employers Health, CVS Health, and others.

Also proposing changes to Part B cost sharing

 is the Biosimilars Council. In a new component of its white paper on barriers to biosimilars, the industry group proposes both waiving cost sharing for patients when a biosimilar is administered and implementing a shared-savings model for biosimilars. In Part D, the group proposes making biosimilars subject to lower cost sharing, ensuring automatic coverage of biosimilars immediately after launch, placing biosimilars on separate formulary tiers to reduce patient cost sharing, and providing specialty tiers for biosimilars above the CMS specialty threshold.

AARP also highlighted the problem of high annual drug costs; a new report issued this month finds that retail prices for widely used prescription drugs increased by an average of 4.2% in 2017, while the general inflation rate was 2.1%. The report also found that, during 2017, the average annual retail cost for drugs used to treat chronic conditions was almost $20,000 per year, or nearly 

20% higher than the average Social Security retirement benefit

Issuing a report of its own was America’s Health Insurance Plans (AHIP), which shed light on what it views as drug makers’ gaming of the Orphan Drug Act’s incentives to develop products for the treatment of rare diseases. Drugs including brand-name etanercept, infliximab, and adalimumab, all of which are top-selling products, 

carry orphan indications that confer benefits

 like 7-year market exclusivity from the date of orphan designation approval, a 50% tax credit for expenses incurred during clinical testing, and a waiver of the New Drug Application fee.

The House Ways and Means Committee also published new data this month showing the extent to which 

 than do patients in other countries. The report examines patterns of US drug pricing relative to other international comparator countries, and it found that Danish patients spent on average $318 annually per capita, the lowest in the study, while US patients paid $1220 each year per capita, the highest.

As a proposed answer to some of these problems, House Speaker Nancy Pelosi, D-California, 

unveiled her plan to bring down drug prices.

 Under the plan, HHS would be authorized annually to negotiate prices for up to 250 of the most costly drugs that lack a generic or biosimilar competitor. The maximum price for a drug would be determined using a blend of international prices that must not exceed 1.2 times the average price in Australia, Canada, France, Germany, Japan, and the United Kingdom. 

HHS would also be allowed to assign penalties to companies that refuse to negotiate their prices. While the plan shares some features with the Trump administration’s blueprint to bring down the cost of drugs—such as using an international index to determine prices&mdash;it remains to be seen whether the plan can be passed in the Senate.

 for biosimilar stakeholders were introduced this month: The Bolstering Innovative Options to Save Immediately on Medicines would temporarily increase reimbursement for biosimilar drugs in a 5-year effort to help increase their use, while the Advancing Education on Biosimilars Act of 2019 would create federal programs to promote biosimilars, including the development of continuing education programs for healthcare providers.

Additionally, the Safe Step Act of 2019 was introduced in the Senate this month. This item of legislation would amend the Employee Retirement Income Security Act to 

require group health plans to provide an exception process

 for step therapy so that patients can access treatment without delays.

The bill comes shortly on the heels of the American College of Rheumatology’s release of 

survey findings that show that step therapy is being widely used

, with 46.49% of patients with rheumatological diseases having been required to undergo step therapy in the past year. Step therapy is often used to require that patients take less expensive, often older drugs before gaining access to products like biologics and biosimilars.

Meanwhile, the war of words between Peter Bach, MD, and his detractors continued; Bach and coauthors have argued that that biosimilar competition is an inefficient way to achieve the goal of lower prices for drugs and that the US government should instead regulate the prices of off-patent originator biologics. Critics, including authors from the American Enterprise Institute, weighed in as well, saying that Congress can make changes to the law to help biosimilars get a foothold in the US market.

 in an interview, Amitabh Chandra, PhD, Ethel Zimmerman Wiener professor of public policy and director of health policy research at the Harvard Kennedy School of Government, said that, while what Bach and colleagues propose is not impossible, 

the US government has had little success with price regulation

: “You can see that all the time with the postal service, with the railroads. Every time we try to do it, it’s not particularly clear that we do a good job.” Chandra added, “My own sense of this is that we need more regulation to increase and expedite their entry. We do not need regulation that goes as far as price regulation.”

Former FDA Commissioner Scott Gottlieb, MD, also 

weighed in on this issue of roadblocks to biosimilars

; speaking with The Center for Biosimilars

 in an interview, Gottlieb said that the United States should consider eliminating safe harbor for drug manufacturers’ rebates for biologics when biosimilars enter the marketplace. “The existence of a rebate, or the ability to rebate off of the incumbent biologic, truly is anticompetitive in that setting,” Gottlieb said.

Biosimilar Policy Roundup: September 2019

This month, 2 biosimilar developers announced expansions of their research and development (R&D) capacities with the acquisition of new sites.

First, Fresenius Kabi announced the expansion of its biosimilar research activities in a new center in Eysins, Switzerland. The R&D center, in which the drug maker says it has invested approximately €15 million (US $16.5 million), will allow the company to intensify its biosimilar research in its focus areas of immunology and oncology.

Fresenius’ biosimilars unit currently has more than 100 employees, and the company says that it plans to expand this team by adding experts from different areas of specialization within biosimilars and biosimilars development in the future.

“Today is a big day for Fresenius Kabi and our Biosimilars business,” said chief executive officer (CEO) Mats Henriksson in a 

. “We are committed to finding the best answers for patients and healthcare professionals. Biosimilars are an outstanding way to help us fulfill our responsibility to provide high-quality products for the treatment and care of critically and chronically ill people. It is a fast-growing segment, and with these additional capacities in research and development, Fresenius Kabi will further strengthen its biosimilars pipeline.”

In addition to its EU-approved biosimilar adalimumab, 

, Fresenius Kabi’s biosimilar pipeline includes a tocilizumab biosimilar and a pegfilgrastim biosimilar, both in late-phase development, multiple undisclosed candidates that are in early development.

Separately, Biocon announced that its subsidiary, Biocon Biologics, has acquired R&D capital assets for a 60,000-square foot biologics research facility in Chennai, India.

The facility will accommodate 250 scientists, and will house an early-stage research and innovation center that will included a pilot-scale R&D unit, cell line development, drug substance process development, formulation laboratories, and analytical laboratories.

Biocon says that it plans for the facility to be operational in the coming months after qualification.

Christiane Hamacher, PhD, CEO of Biocon Biologics, said in a statement that “The high-end integrated R&D facility in Chennai will enable Biocon Biologics to expand its R&D capability and accelerate its journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide. This investment will allow us to fast-forward development of our biosimilars from lab to pilot scale. R&D is at the core of what we do and I believe this facility will enable us to pursue breakthrough innovation in pursuit of providing affordable access to high quality biosimilars and inclusive healthcare solutions aimed at transforming patient lives globally.”

Currently, Biocon boasts US- and EU-approved biosimilars of trastuzumab and pegfilgrastim, as well as an EU-approved insulin glargine biosimilar. The drug maker is developing various biosimilar assets together with Sandoz, as well as products including pertuzumab, filgrastim, bevacizumab, insulins, and others with Mylan and local partners.

Biosimilar Developers Expand R&D Capabilities With New Facilities

Today, the FDA released a new suite of resources to educate patients about biosimilars.

,” explain that biosimilars are safe and effective medications that “are FDA-approved biologic medications that are compared to another medication—the original biologic.” The FDA describes biosimilars are being made “from natural sources” and developed “using advanced science.”

The resources explain that biosimilars can be expected to have the same benefits and risks, and that they may provide more treatment options, increase competition in the marketplace, and allow for lower costs.

The FDA also provides a brief overview of the ways in which it ensures that biosimilars are safe and effective, including reviewing data, monitoring drugs post-launch, and reviewing patient safety reports.

A frequently-asked-question (FAQ) section of the guide addresses questions such as how patients can tell whether they are receiving a biosimilar (the FDA suggests asking a doctor or pharmacist), whether it is safe to switch to a biosimilar (biosimilars can generally be used whether or not a patient has been first treated with a reference, says the guide), and whether individual patients can expect to see cost savings from biosimilars (health insurance plan providers are best situated to provide this information, according to the FAQ).

The FDA’s materials also include a “Biosimilar Basics” 

 of biosimilars that highlights the fact that “prescribers and patients should have no concerns about using these medications instead of reference products.”

The resources deliver on the Biosimilar Action Plan’s commitment to develop effective communications to improve upon the understanding of biosimilars among patients and other stakeholders. In the plan, the FDA 

 to developing a “one-pager” for patients and to pursue video-format communications that can be disseminated on social media for patients and other key audiences.

Today, the FDA released a new suite of resources to educate patients about biosimilars.
 

FDA Releases Biosimilar Educational Materials for Patients

Two biosimilar bills, both with bipartisan sponsors, were unveiled last week and aim to boost uptake in the United States, one through increased Medicare Part payment and the other via additional education.

Payment for biosimilars in Medicare Part B would get a temporary boost through the Bolstering Innovative Options to Save Immediately on Medicines Act (BIOSIM), which would temporarily increase reimbursement for biosimilar drugs to the average sales price (ASP) plus 8%, up from the current 6% plus ASP. The larger payments would last for 5 years in an effort to help increase their utilization by doctors administering the drugs.

Medicare patients pay a 20% percent coinsurance on Part B drugs; spending on Part B drugs totaled $21.5 billion in 2014.

The BIOSIM Act is from Rep. Kurt Schrader, D-Oregon, and Rep. Greg Gianforte, R-Montana.

“Biosimilars have long struggled to grow in utilization and the BIOSIM Act will help them gain market share by providing an incentive for biosimilars that are lower cost than the biologic,” Schrader said in a statement. “Costs for patients and the healthcare system will go down with the transition to greater use of lower cost biosimilar drugs. There is no doubt that this bill is a win-win for patients and providers.”

Gianforte added, “I often hear from Montanans about the skyrocketing costs of their prescription drugs and the challenges they face to pay for them. This bipartisan bill provides incentives for using biosimilar drugs over biologics. With increased use of biosimilars, patients will see lower out-of-pocket costs for the medications they need, and taxpayers will save money.”

The Biosimilars Forum, which represents biosimilar drug makers, praised the introduction of the act, saying in a statement that “This legislation will help guide physicians to lower-cost, safe, and effective treatment options that reduce the financial burden for both patients and taxpayers. Enhancing provider reimbursements through an increased ASP add-on is essential to increasing biosimilars uptake and saving billions of taxpayer dollars.”

In another bill, Representatives Eliot Engel, D-New York, and Larry Bucshon, R-Indiana, 

 the Advancing Education on Biosimilars Act of 2019. This bill is a companion bill to one introduced in the Senate earlier this year by Senators Mike Enzi, R-Wyoming, and Maggie Hassan, D-New Hampshire. Their bill, 

, the Lower Health Care Costs Act, passed the Senate Committee on Health, Education, Labor and Pensions in June.

The bill would create federal programs to promote biosimilars, including the development of continuing education programs for healthcare providers. In addition, the bill would require the FDA to create a public website to educate patients and providers about biologics and biosimilars, including providing information about interchangeability and processes for reporting adverse events that pose a risk to patient health and safety.

The American Hospital Association supports the public education bill.

“America’s hospitals and health systems thank Reps. Engel and Bucshon for their bipartisan efforts to facilitate the increased use of biosimilar drugs, including the importance of interchangeability, by educating providers, patients and other key stakeholders on their clinical value,” said Tom Nickels, AHA executive vice president, 

. “This will give patients greater access to affordable, innovative drugs.”

Two biosimilar bills, both with bipartisan sponsors, were unveiled last week and aim to boost uptake in the United States, one through increased Medicare payment and the other via additional education.

2 More Bills Aiming to Boost Biosimilars Introduced in Congress

This week, Russian drug maker Generium announced that it has received approval for—and has launched&mdash;its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.

, references Genentech’s Pulmozyme, a drug used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis. Unlike many biologic therapies, which are infused or injected, dornase alfa, a recombinant human deoxyribonuclease I enzyme that selectively cleaves DNA, is administered by inhalation using a jet nebulizer.

“We believe patients will be able to maintain a higher quality of life on our dornase alfa inhalation solution,” said Dmitriy Kudlay, MD, PhD, chief executive officer of Generium, in a statement 

 the launch. “The orphan drugs market has been growing significantly over the last several years. Biotechnology, as a science, is developing rapidly, providing new products for the treatment of the most severe and rare diseases.”

The biosimilar was developed using proprietary technology from Selexis; the company’s platform uses novel human DNA-based elements that control the organization of chromatin across mammalian cells. These elements increase transcription rates of transgenes and allow for higher and more stable expression of recombinant proteins.

Selexis indicated in a statement that there are currently 122 clinical programs worldwide that are using its platform and that the dornase alfa biosimilar represents the sixth approval for a product developed using this technology.

Generium was also the first drug maker to receive 

 for a biosimilar eculizumab (referencing Soliris), also in Russia. The rare disease drug was approved in April 2019 for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

This week, Russian drug maker Generium announced that it has received approval for&mdash;and has launched&mdash;its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.