The Center for Biosimilars Staff

 today that it has signed a collaborative agreement with Takeda to co-develop multiple novel biologic drugs that will target currently unmet needs. The companies’ first project, which they will begin developing immediately, is TAK-671, a prospective treatment for severe acute pancreatitis.

The agreement marks the first foray into novel biologics for Incheon-based Samsung Bioepis; the company has thus far focused entirely on developing biosimilar treatments. Christopher Hansung Ko, president and CEO of Samsung Bioepis, called the agreement a new chapter in the company’s history, and said that “[5] years ago, we entered the biopharmaceutical industry with a strong determination to transform the way therapies are brought to patients by replacing legacy processes with new and innovative ones. Together with Takeda, we look forward to realizing this goal vision by accelerating the development of effective therapies for patients who are currently without a viable treatment option.”

Takeda’s head of the center for external innovation, Daniel Curran, MD, said that it looked forward to the companies’ collaboration and its ability to fuse “our unique capabilities in development and manufacturing along with fresh and innovative clinical approaches.”

 that Samsung Bioepis’ move to diversify its pipeline could provide the company with a cushion as it waits to reap the rewards of its investments in the biosimilar space. Samsung Bioepis has invested approximately $1.3 billion in biosimilar research and development since it was founded in 2012.

So far, the company has earned $250 million in sales for its etanercept biosimilar, marketed as Benepali, since it launched in the European Union (EU). The company has also gained EU and US approval for its biosimilar infliximab (

), which launched in the US market in July 2017. It is also awaiting European Medicines Agency decisions on its adalimumab and trastuzumab biosimilars. In the United States, the company is looking ahead to final FDA 

 of its follow-on insulin glargine, developed in partnership with Merck, following conclusion of a litigation over a patent dispute with Lantus’ sponsor, Sanofi.

Despite a delay in seeing returns on its substantial investments, Samsung Bioepis does not show signs of backing away from its biosimilar development; the company is currently in phase 3 clinical trials with its 

Articles

Biosimilar developer Samsung Bioepis announced today that it has signed a collaborative agreement with Takeda to co-develop multiple novel biologic drugs that will target currently unmet needs.

Biosimilar Developer Samsung Bioepis to Collaborate With Takeda on Novel Biologics

A recent report examined the products and projects targeting diabetes and diabetes-related complications are in the current biopharmaceutical pipeline. Our infographic details the key findings.

Infographic: The Diabetes Pipeline

Pharmacy Benefit Manager (PBM) CVS Health, which has over 90 million members, has 

 the results of a survey it conducted of approximately 2000 people in the United States concerning patient perceptions of generic and biosimilar medications.

Of the respondents, 60% reported taking prescription drugs. Among that group:

72% reported that they paid less than $50 each month for their medications, and 85% reported paying less than $100 each month

58% reported taking more than 3 prescriptions

Overall, the survey demonstrated acceptance of generic drugs:

85% reported spending less money, while receiving the same effects, by switching to a generic

80% said that they would accept a generic if it would reduce their out-of-pocket spending

Some respondents also saw the potential to benefit from biosimilar medications:

60% reported that they would accept a biosimilar in place of a branded biologic if it would provide them with a cost savings

CVS Health notes that, in 2016, clients who used the company’s generics-focused formulary saw an 88.2% increase in the rate of dispensed generics (3.2% higher than the rate for clients using the PBM’s standard formulary). The PBM expects to generate $13.4 billion in savings for its clients over the 2012 to 2018 period through including more low-cost drugs on its formularies, encouraging patients to switch to available generics, and including biosimilars in its formulary 

The PBM says that specialty pharmaceuticals, including biologics, are responsible for approximately 36% of its total spending, and cited RAND Corporations projection that biosimilars in the specialty marketplace could reduce spending on biologics by $44.2 billion over the coming 10 years. Last year, CVS Health indicated its intention to move toward greater biosimilar use to reap some of those savings: its 2017 

 employed biosimilar filgrastim (Zarxio) as a replacement for its reference (Neupogen). It also replaced reference insulin glargines (Lantus and Toujeo) with a follow-on (Basaglar). In its 2018 

, the PBM stopped short of including the newly launched biosimilar infliximab (Renflexis), but noted that “The autoimmune class is a leading trend driver for commercial clients,” and said that it will evaluate its formulary in light of new product entries. 

 to CVS Health’s shift toward biosimilars last year with a call for patient and practitioner choice: AMA president Andrew Gurman, MD, said that “Patients should have the opportunity to choose from a wide range of available therapies. Certainly, biosimilars show great promise, but ultimately, it is important that the patient and his or her physician maintain the ability to choose the best therapy for that particular patient and situation.”

Pharmacy Benefit Manager CVS Health, which has over 90 million members, has released the results of a survey it conducted of approximately 2000 people in the United States concerning patient perceptions of generic and biosimilar medications.

CVS Health Survey Finds Patients Ready for Cost-Saving Biosimilars

Hi, I’m Kelly Davio for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars. 

Here are the top 5 biosimilars articles for the week of August 14.

withdrawn its filings for 2 biosimilars in Europe ahead of a re-inspection of its Bangalore manufacturing facility.

 The move sparked new questions as to whether the company’s trastuzumab will be cleared by the FDA next month.

Number 4: Dr Marcus Snow, of the University of Nebraska Medical Center, joined The Center for Biosimilars

discuss the use of biosimilar treatments in children

Number 3: With drug price reform efforts apparently stalled at the federal level, 

states are leading the fight against rising drug costs.

Number 2: A recent budget impact analysis shows that 

discounts for biosimilar infliximab may need to be deeper than previously believed

Rebates provided to PBMs by reference product sponsors

 may pose a threat to biosimilar uptake, and could force patients to pay high out-of-pocket costs.

Finally, last week, our newsletter asked you to share your thoughts on switching studies, and whether such studies should use a US-licensed reference product, an EU-licensed product, or a product approved by any global healthcare agency. 

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To read these articles and more, visit centerforbiosimilars.com.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 2017.

The Top 5 Biosimilars Articles for the Week of August 14

Drug maker Biogen recently announced that it has developed a framework to predict outcomes in specific patient populations taking its drugs in order to arrive at the best value-based pricing agreements with payers. Such agreements attempt to correlate the prices charged for therapies with the benefits that patients obtain from them. Jen Norton, vice president of market access for Biogen, said in an 

 that the company has struck 4 such agreements so far.

, which focus on Biogen's multiple sclerosis drug portfolio, are with 3 healthcare systems—Harvard Pilgrim Health Care, SelectHealth, and Moda Health&mdash;and with the pharmacy benefit manager Abarca Health. "We believe this pilot will provide valuable information that we can apply to future contracting approaches as we work to tie the pricing of our products to the clinical value and expand formulary access for patients," said Michel Vounatsos, Biogen's CEO. 

Biogen—developer of biosimilar etanercept, infliximab, and adalimumab&mdash;

 that in pricing its products, it hopes to strike a balance among key business principles. It sees the need to uphold the clinical value of its therapies, the impact of its drugs on health systems, and returns on investment. To that end, it employs its value framework and engages payers and Health Technology Assessment (HTA) authorities early in the process of drug development in order to better understand the types of evidence that it will need to produce to gain reimbursement for its drugs.

Such approaches are becoming increasingly common in the pharmaceutical industry; Forbes recently 

 that approximately 25% of health plans now have at least 1 value-based payment contract with a drug maker, and that an additional 30% are currently negotiating outcome-based contracts.

Yet, as Dana Goldman, PhD, and Anupam Jena, MD, 

, measuring the value of a given therapy can be fraught with challenges. Differences in assumptions used in value assessments can dramatically alter the outcomes of assessments, and can “distort the cost effectiveness of a therapy and lead to unsound coverage decisions and wasted resources.”

Among the challenges inherent in developing an appropriate framework, say Goldman and Jena, is the problem of choosing appropriate data sources and updating data as evidence develops. Because real-world patients may be sicker, have less monitoring, or demonstrate less adherence to their treatments than patients in clinical trials, the choice between real-world data and clinical trial data can impact the accuracy of the cost assessment.

The common HTA practice of using list prices for drugs—rather than prices that health plans will pay after 

 or discounts—can also skew perceptions of cost, as the difference between list prices for generics or biosimilars and their branded products may overstate the cost savings produced by using a follow-on product. 

While drug makers and health plans may not yet have perfected their approaches to creating value-based contracts, Norton indicates that at Biogen and elsewhere, the industry is looking to such frameworks as a way to address the problem of high drug costs. “As an industry, we're still working through ways to truly tie price to that value that's realized by the patient,” Norton said. “Building a model that's thorough, that's measurable, that's objective, and to figure out how to measure that value is the critical step where we're at today.”

Drug maker Biogen recently announced that it has developed a framework to predict outcomes in specific patient populations taking its drugs in order to arrive at the best value-based pricing agreements with payers.

Value-Based Drug Pricing: a Challenging Approach to Cost Control

While US healthcare providers are growing more 

 to adopt lower-cost biosimilar drugs as way to address the rising costs of biologic treatment, biosimilar developers are facing yet another challenge: competing against reference products for a preferred place on formularies.

 this week that Ascension Health, a nonprofit hospital system in St. Louis, Missouri, had hoped to begin using biosimilar infliximab (Inflectra), which is listed at a 15% discount to the branded infliximab product (Remicade), in order to reduce its $55 million spend on infliximab treatment. However, the health system soon learned that insurers overwhelmingly preferred to cover the branded treatment despite the lower list price of the biosimilar.

article also notes that UnitedHealth Group, the nation’s largest insurer, continues to prefer reference infliximab, and that pharmacy benefits managers (PBMs) Express Scripts and CVS Caremark also list the branded drug as their preferred infliximab treatment. What’s behind these choices to prefer higher-priced innovator drugs to biosimilars? Many industry experts point to pricing negotiations among members of the supply chain as a primary factor.

As the makers of branded drugs seek to maintain their market share in the face of biosimilars and generic drugs, they become incented to offer rebates to PBMs and health systems that make their innovator products competitive with the lower-price options. As Kyle Skiermont, PharmD, COO of Fairview Pharmacy Services, 

in a recent interview, “We originally thought that, if there was a 15% to 20% price difference [for biosimilars], we’d see a lot of movement. We don’t know, when we see that price difference, if the downstream costs really are that different.”

Just how different those downstream costs can be post-rebate for PBMs and the health plans with which they contract is impossible to assess. As the 

, PBM contracts with health plans are regarded as trade secrets, and are concealed from both the public and from other health plans. “The PBMs are sitting at the center of a big black box,” Linda Cahn, a drug pricing consultant, told the 

. “They’re the only ones who have knowledge of all the moving pieces.”

 say that PBM cost savings through rebates are not necessarily passed along to patients; while PBMs may pay far less than list price for expensive drugs like reference infliximab, patients must still pay copays, coinsurance, and other out-of-pocket costs on a drug’s list price. For the 

 of Americans who have high-deductible insurance plans, those costs can create a significant strain on household budgets.

Patients, though, could see some relief from those costs from an unlikely source: Amazon is rumored to be entering the pharmaceuticals business. As 

, Goldman Sachs analysts see strong potential for the Seattle-based retailer to disrupt the drug supply chain and its $125 billion in annual profits by leveraging its robust logistics and distribution systems. The report suggests that Amazon could potentially offer its own PBM in conjunction with an online pharmacy, and that its entrance into the supply chain could drive a greater trend toward transparency in drug pricing.

While US healthcare providers are growing more willing to adopt lower-cost biosimilar drugs as way to address the rising costs of biologic treatment, biosimilar developers are facing yet another challenge: competing against reference products for a preferred place on formularies.

Price Deals for Reference Products Pose a Threat to Biosimilars

Although the use biosimilar infliximab in rheumatoid diseases and inflammatory bowel disease has the potential to reduce the treatment costs, a variety of factors may influence the adoption of biosimilar treatments and their potential impacts on healthcare budgets. A recently published budget impact 

 funded by Hospira evaluated the impact of adopting biosimilar 

 for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn’s disease (CD), and ulcerative colitis (UC) in the United Kingdom (UK), Germany, France, Spain, and Italy (the EU5) in the context of other other available biologics, including reference infliximab and other innovator biologics.

The researchers updated an existing budget impact model to include all currently available biological drugs in the EU5 for the treatment of RA, AS, CD, and UC. The model was informed by epidemiological parameters derived from published literature reviewed in July 2015, and market shares of biologics were derived from data provided by Therapy Watch for the years 2012 and 2013. Three types of costs were included in the analysis: annual acquisition costs, administration costs, and therapy monitoring costs. In the base case analysis, existing patients were assumed to remain on an existing biologic treatment or switch to a biosimilar, while naïve patients could be allocated to any available biologic, including biosimilar infliximab. Price discounts for biosimilar infliximab compared with the reference were based on national list prices: 10% (UK), 14% (Germany), 0% (France), 18% (Spain), and 25% (Italy). The time horizon of the model was 5 years, from 2015 to 2020.

A total of 35 leading rheumatologists and gastroenterologists from the EU5 participated in the first round of a 2015 Delphi survey. Of that group, 17 agreed to participate in a second round of the survey. The panel was asked to forecast the uptake of biosimilar infliximab and estimate the proportion of patients eligible for a particular type of biological treatment. The survey respondents indicated that they believed the efficacy and safety of biosimilar infliximab was comparable with that of the reference in rheumatology and gastroenterology indications. Scenarios considered by the panel were the following:

A biosimilar infliximab available at a 50% discount to the reference

A biosimilar infliximab available at a 75% discount to the reference

Availability of clinical and observational study evidence confirming efficacy and safety of biosimilar infliximab in extrapolated indications (CD and UC)

Availability of vedolizumab for the treatment of CD and UC

Availability of a biosimilar etanercept for the treatment of RA and AS

Availability of a rituximab biosimilar for the treatment of RA

 Based on this model, the researchers projected that, by the year 2020, the percentage of total patients receiving biosimilar infliximab for rheumatology and gastroenterology indications, respectively, in the EU5 would be as follows: 

The researchers found that, for all indications studied, the total market share of biosimilar infliximab was driven primarily by an increasing share of naïve patients who would be prescribed the biosimilar over time. The percentage of naïve patients in the EU5 who would receive biosimilar infliximab for rheumatology and gastroenterology indications, respectively, by 2020 were as follows:

In the base case analysis, in all EU5 countries except France—where budget was largely unaffected for RA&mdash;spending on the rheumatology indications studied was reduced following biosimilar adoption. In the remaining nations, savings were obtained from biosimilar adoption for RA at year 5 (2020). Spending for AS increased in the UK and France, though savings were observed in Germany, Spain, and Italy.

Base case analysis for gastroenterology indications revealed that biosimilar infliximab adoption decreased budgets only for Spain and Italy. Budgets increased over the 5-year horizon for the UK, Germany, and France (the researchers note that presumed availability of vedulizumab in the UK and Germany had a large effect on total budget).

However, the analysis demonstrated that specific factors could influence the budget impact of the biosimilar’s adoption:

If the price of biosimilar infliximab was set at a 50% discount to the reference, biosimilar adoption decreased budgets in all EU5 nations. In rheumatology, the savings produced in 2020 ranged from €22 million in France to €81 million in Italy. In gastroenterology, budget savings ranged from €12 million in Italy to approximately €250 million in the UK.

If the biosimilar’s price was set at a 75% discount to the reference infliximab, savings in rheumatology ranged from €66 million in France to €289 million in Germany. In gastroenterology, savings ranged from €24 million in Italy to €340 million in the UK.

The researchers concluded that the introduction of biosimilar infliximab would lead to increasing budgets in some countries, and would only lead to modest savings in other countries. Because savings were produced only when discounts reached 50% or more, the authors state that policy makers should ensure substantial price reductions in order to spur physician uptake of biosimilars and generate cost savings in healthcare budgets.

Although the use biosimilar infliximab in rheumatoid diseases and inflammatory bowel disease has the potential to reduce the treatment costs, a variety of factors may influence the adoption of biosimilar treatments and their potential impacts on healthcare budgets.

Budget Impact Analysis Shows a Need for Deep Discounts for Biosimilar Infliximab

 its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.

In its March decision, the Delhi High Court 

 that Biocon and Mylan could market their trastuzumab to treat metastatic breast cancer, early breast cancer, and metastatic gastric cancer. Previously, Biocon and Mylan marketed their product (sold under the names CANMAb and Hertraz) for metastatic breast cancer only. The ruling, based upon approvals for the drug that were granted by the Drugs Controller General of India (DCGI), also allowed Biocon and Mylan to use Roche’s product data in their own labeling.

In the March case, Roche argued, unsuccessfully, that use of its clinical efficacy and safety data constituted an attempt on Biocon and Mylan’s part to capitalize on the Swiss drug maker’s product without having to conduct their own clinical trials. The Court agreed with Biocon and Mylan that Roche’s labeling was both publicly available and unprotected under Indian law, which does not recognize data exclusivity.

In its SLP, Roche attempted to challenge the approval that the DCGI had granted to Biocon and Mylan for their biosimilar of its innovator trastuzumab (which it has marketed in India under the names Herceptin, Herclon, and Biceltis). Roche claimed that allowing the biosimilar’s package insert to utilize Roche’s data denied patients and providers the chance to make informed decisions about breast cancer treatment.

In explaining why Roche dropped its petition over its blockbuster drug, some analysts point to an ongoing 

 into ostensible anticompetitive practices undertaken by Roche. India’s antitrust regulator, the Competition Commission of India, announced in April that it was launching a detailed investigation into Roche’s practices with respect to trastuzumab after Mylan and Biocon filed a petition alleging that the drug maker had tried to thwart competition for its drug by misleading medical professionals.

 with Roche in a US litigation concerning trastuzumab. In the March settlement, Roche agreed to grant the biosimilar developers a global license—exclusive of Japan, Brazil, and Mexico&mdash;in exchange for dropping 2 US-based challenges to its patents for the drug.

Mylan and Biocon’s product, currently under consideration at the FDA under the name MYL-1401O, received a unanimous recommendation of approval from the FDA’s Oncologic Drugs Advisory Committee on July 13. Final US regulatory action on the drug is expected by its user fee date of September 3, 2017.

Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.

Roche Withdraws SLP Against Biocon and Mylan's Trastuzumab Biosimilar

Spherix Global Insights’ recently released survey of 103 US gastroenterologists yields 3 key takeaways concerning the future of the increasingly competitive ulcerative colitis market. 

Infographic: The Developing Ulcerative Colitis Market

Here are the top 5 biosimilars articles for the week of August 7.

telling consumers that they must purchase brand name drugs,

 even when cheaper generics are available, leading to higher out-of-pocket costs for patients.

Number 4: The FDA’s Office of Surveillance has released findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore. 

The investigators found 10 problems, including issues with labeling and sterility.

Number 3: A recent study comparing biosimilar 

GP2013 to both EU- and US-approved rituximab shows 3-way PK and PD equivalence

Number 2: FDA Commissioner, Dr Scott Gottlieb, 

has formed a new working group within the agency. 

The group will focus on increasing generic competition.

And Number 1: Pharmacist Kyle Skiermont, COO of Fairview Pharmacy Services, 

discusses his experience with payers and healthcare providers

 as they prepare for the impact of biosimilar drugs and non-medical switching.

Finally, last week, our newsletter asked you to share your thoughts on whether interchangeability will be important to the uptake of biosimilars. To view results of the poll, follow 

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 7, 2017.