U.S. FDA Announces Approval of Amjevita

PBIRx®

Intelligent Solutions in Pharmacy Benefits

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On September 23, 2016, the U.S. Food and Drug Administration officially announced their approval of Amgen’s Amjevita as a biosimilar to Humira. Amjevita is the fourth biosimilar to receive approval from the U.S. FDA, and has been approved to treat seven of ten Humira indications.   

Approved Indications

As is stated in the FDA’s press release, the indications that Amjevita has been approved for are (in adult patients):

1. Moderately to severely active rheumatoid arthritis.
2. Active psoriatic arthritis.
3. Active ankylosing spondylitis.
4. Moderately to severely active Crohn’s disease.
5. Moderately to severely active ulcerative colitis.
6. Moderate to severe plaque psoriasis.
7. Moderately to severely active polyarticular juvenile idiopathic arthritis (for patients four years old and up).

The biosimilar is NOT approved for use in pediatric Crohn’s Disease, Hydradenitis Suppurativa, and Uveitis. The approval of Amjevita signifies an important milestone for California based Amgen, as this is their first biosimilar to receive FDA approval. As a reminder, in order to be approved by the U.S. FDA, a biosimilar must prove that it is extremely similar to a biological product that has previously received approval, and there must be no clinical differences between the two products where purity, potency and safety are concerned. 

Side Effects

As with all treatments, possible side effects have been provided for prescribers and patients to review. The most serious to note are malignancies and infections, and the FDA explains that they expect the most common side effects to be infections and reactions at the injection site. Just like Humira, Amjevita also comes with a Boxed Warning that alerts of an increased risk of serious infections that could potentially result in hospitalization or be fatal.

Although Amjevita has received its approval now, FiercePharma reports that it could be a while before it actually makes its way into pharmacies. This results from a 180-day notice period that is required, as well as a legal issue between AbbVie and Amgen. AbbVie, which is the manufacturer of Humira, has reportedly sued for patent infringement and requested that the courts block Amjevita upon receiving FDA approval. AbbVie, recognizing that they will lose market share to biosimilars, has also had several Average Wholesale Price (AWP) increases for Humira in the past 12 months of over 28% dramatically impacting payor’s pharmacy benefit spend. 

It will be interesting to see how biosimilars are treated by Pharmacy Benefit Managers and how biosimilars are accepted and dispensed by physicians and health plans in 2017. 

If you have questions about the FDA’s latest approval and how it could impact your current health care spend, please give us a call at (888) 797-2479. We at PBIRx are always on the lookout for new approvals and analyzing how they will affect pharmacy benefit spend, and would be happy to speak with you further about the topic.

FDA Approves Inflectra, First Monoclonal Antibody Biosimilar

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On April 5, 2016, the U.S Food and Drug Administration approved the second biosimilar in the United States, which is infliximab-dyyb (Inflectra), a biosimilar to inflixamab (Remicade). Inflectra is manufactured by Celltrion, Inc. for Hospira, a Pfizer company, and will be administered by intravenous injection for many of the same indications as Remicade, the originator/reference drug. 

Although the biosimilar of Remicade has just been introduced to the U.S market, Inflectra and other Remicade biosimilars have already been introduced to major European markets such as Germany, France, Italy, Greece, Spain and Austria.

According to the FDA, Inflectra can be prescribed to treat the following patients:

• Adult and pediatric patients over age 6 who have moderate to severely active Crohn's disease and have not had success with conventional therapy
• Adult patients who have moderate to severely active ulcerative colitis and have not had success with conventional therapy
• Adult patients who have chronic severe plaque psoriasis
• Patients who have moderate to severely active rheumatoid arthritis - to be used in combination with methotrexate
• Patients who have active arthritis of the spine
• Patients who have active psoriatic arthritis

As a reminder, biosimilars are biological products, meaning they are derived from living organisms such as humans, animals, yeast and microorganisms. In order to be approved, biosimilars must be extremely similar to a biological product that has already been approved, and clinically speaking, there must be no differences in safety and effectiveness when compared to the biologic or reference product.

In addition to being only the second biosimilar approved by the FDA, Inflectra is the first monoclonal antibody biosimilar to be approved. Monoclonal antibodies are made by just a single clone of cells or cell lines from a parent cell, and though they are very expensive, they are utilized widely for different disease states such as cancer, psoriasis and rheumatoid arthritis.

Regarding the dispensing of Inflectra, it is important to note that it must receive approval for dispensing by a physician since the FDA guidance states that it has “not” been approved as an interchangeable product.

With a new biosimilar hitting the market, it is important for entities that provide pharmacy benefits to be aware of how this could affect future pharmacy benefit spend. There is a good chance that pharmacy benefit managers will hold up the dispensing of biosimilars in order to maintain the hefty rebates they receive from the high cost specialty brand/originator products. As such, this is an example of the value of retaining an expert in the pharmacy benefit industry, like PBIRx, to review your PBM contract language so that you have a clear understanding of how biosimilars are being treated, i.e. excluded/included from formularies, pricing guarantees, discounts, and copay tier appropriation.  

For help understanding your PBM Agreement, call and request a courtesy review of your PBM Agreement with one of our friendly and experienced PBM Experts prior to signing a three year PBM Agreement, which could be great for the PBM profitability, but not as good for your bottom line pharmacy benefit spend. Please call (888) 797-2479 or fill out our contact form on our website.

Biosimilars vs. Biologics - What's The Difference?

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Though plan sponsors may be responsible for providing one or more types of benefits to employees or members, one of the most commonly misunderstood is the pharmacy benefit. Why? With so many categories of drugs out there, each with their own requirements and guidelines, there is a vast amount of information that must be processed to be fully aware of how and where costs are being distributed.

To breakdown drug categories a bit further and focus on a new class of high cost specialty drugs, we would like to focus on biologics and biosimilars, beginning with the BPCIA:

The Biologics Price Competition and Innovation Act (BPCIA) is a piece of the Affordable Care Act that states that a biological product can be considered a biosimilar if data suggests that it is already extremely similar to a previously approved originator biologic specialty drug. Essentially, it encourages the development of a biosimilar once the originator specialty biologic's (the drug that was originally approved) exclusivity ends (typically after 12 years). In current news, Presidential candidates are proposing to reduce the 12 year exclusivity to 7 years.

But what exactly is a biologic or a biosimilar? By definition, biologics are drugs that are derived from natural sources, such as humans, animals or microorganisms. They are designed to treat diseases and other medical conditions, but can be used to prevent disease dependent upon circumstances. When you think of biologics, think along the lines of vaccines, gene therapies and cellular therapies.

On the other hand, biosimilars are a type of biologic that are approved by the FDA because they are similar in nature to other already FDA approved biological products often referred to as the originator drug. However, it is important to note that some biosimilars may not be interchangeable with the originator drug depending on the type of FDA approval.

Where cost is concerned for biosimilars vs. biologics, biosimilars have been predicted to reduce drug spending by the billions over 10 years. Some of the most current biosimilars that have already launched and others that are expected to hit the market this year are:

• Zarxio (for Neupogen)
• Infliximab (for Remicade)
• Epoetin Alfa (for Epogen)

Tying it all back to plan sponsors, they must be prepared to take advantage of cost savings by changing their plan designs to encourage Specialty Drug biosimilar utilization. Since some are infusible drugs, they need to either carve the originator drug from the medical to the pharmacy benefit for prior authorization and opportunity for biosimilar dispensing OR, put a trigger in place for medical approval to prefer the lower cost biosimilar.

For more information about biosimilars and biologics and how they affect a pharmacy benefit plan, connect with PBIRx today! We can analyze your plan to determine if it is designed in the most cost effective way and educate you further on the difference between each of the current drug categories. To speak with one of our consulting and auditing experts, please give us a call at (888) 797-2479 or email info@pbirx.com today.

Biologics: An Overview

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

By definition, biologics are medical products that are made from natural sources such as a microorganism, a human or an animal. Unlike other drugs that are made through a chemical process, biologics are manufactured in a living system and are usually very large molecules or mixtures of molecules that can not easily be identified. 

Just like other pharmaceutical drugs, biologics are used for the purpose of treating a medical condition or disease. Since biologics have proven to be an adequate solution for the treatment and prevention of some medical conditions, it is expected that over the next decade, the global biologics market will grow tremendously. In fact, at this rate, it is anticipated that by 2018, about 45 of the top 100 drugs will be biologics, pulling in about 50% of sales for that group of drugs.

When discussing biologics, it is also important to touch on their relationship with biosimilars and analyze how the growth of biologics will impact the production and growth of biosimilars as well. First and foremost, a biosimilar is any biological product that is very similar in nature and composition to an already licensed biological product. However, since biologics are extremely complex, it appears that it will be much more difficult for manufacturers to make a biosimilar version of originator biologics. Furthermore, in order to truly understand the safety and effectiveness of such biosimilars, manufacturers will need to carry out clinical trials where these drugs are tested. As a result, one can expect that biosimilar sales may not grow at the same rate as biologics since the process of integrating them into the market will be a much slower one.

At PBIRx, we are always following the latest pharmacy trends to better understand how the industry is changing. In turn, we are able to better analyze our clients' pharmacy benefit plans and develop solutions that are more in tune with the latest industry breakthroughs. For more information on biologics or to find out how we can help you with your pharmacy benefit plan, please visit us on our website or contact us at (888) 797-2479 today.