Cure Click - What a Clinical Trial Means to You!

http://curec.lk/1HmayAK

Clinical Trial possibly in your area, for a new "biosimilar" study!!!

Rheumatoid Arthritis Clinical Trial

The currently recruiting trial listed on CureClick for rheumatoid arthritis is a clinical study for a biosimilar medication. We have received several messages about this trial so we wanted to post some additional information:

According to the FDA, “Biosimilars are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.” 

For this trial, one group will be given the currently approved and available medication Rituxan® (rituximab) and the other will be on a biosimilar version of rituxumab. Neither group will receive a placebo. The goal of the trial is to see if the study drug is as safe and effective in patients with rheumatoid arthritis and attempt to show it has no clinically meaningful difference to the reference product (Rituxan®).

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MORE ABOUT THE STUDY FROM THE SPONSOR:

The purpose of this study is to compare the proposed biosimilar study drug rituximab (GP2013) against a standard approved treatment rituximab (Rituxan®) to see if the study drug is as safe and effective in patients with rheumatoid arthritis.

• The study drug (GP2013 and Rituximab) is administered by IV Injection (IV).
• At least 174 people have already taken this drug in clinical trials
• All study related medications, analysis, hospital visits and procedures are free

Eligibility Criteria:

Participants must:

• be at least 18 years old
• have been diagnosed with rheumatoid arthritis for at least 6 months
• have had inadequate response or intolerance to DMARDs (disease-modifying anti-rheumatic drugs) and 1 – 3 anti-TNF (tumor necrosis factor) therapies
• have received methotrexate for at least 4 months with 25 mg/week as the maximal dose

Participants must not:

• have significant liver disease, or congestive heart failure
• be taking a high potency of opioid analgesics (e.g. methadone, hydromorphone, morphine)

For more information about the study, please visit the link provided to you by your Ambassador.

Biosimilars! The future of much more affordable medications for Autoimmune and Arthritis Illnesses, as well as others.... A Texas Bill to be Passed

I wanted to share with my friends about a very pleasant and surprising phone call I received yesterday evening. It was from the Central Arthritis Foundations (Texas area) Senior VP. I have the honor of meeting her last year at the Arthritis Summit in DC, along with several other incredible people! Each have touched my life in so many ways. She was talking to me about the Summit, plus we have a "bill" in the Texas legislature about "governing" over the "bio-similars" here in our state. Rules to make sure patients get these when they are available, for the reasons why they are being made, which is expense, a major factor for patients. But, the bill is to protect the patient, the physicians, the pharmacies, so that things run smoothly, and patients get the "alternative" if available and if that is what their physicians deem to be okay for them. Anyway, we are having some of our Texas Arthritis Advocates go to Austin next week, and "testify" in front of the legislature about the bill we are supporting, and so forth. If you are here in TX, and these medications will some time in the future apply to you, someone you know and so forth, I wanted to let you know the number of the bill, so you can be familiar with it. It is Bill Support HB 751 / SB 542. OF course the biosimilar medications will definitely be a huge thing for those of us with autoimmune illnesses, arthritis illnesses, as well as other diseases also. They will be something that can help many of us get medications we need, but at a lesser price, which makes them available to many, many more of us. As we go along with this particular bill in our Texas Legislative body, you will see it come up I am sure along the way. It is one you will probably want to keep your eyes on, and we hope we have all the support we can here in TX, in order to get these medications to our fellow Texans as they become available. So, I was invited to go to Austin next week and "testify" in behalf of the AF. I am not sure as of yet, if I will be able to make the trip. I missed Pam's email I believe due to of course "spam" filters, so the original email didn't get to me. She resent it yesterday, so I am looking over the information now, and if things work out, I may consider going down to Austin next week to go in front of the legislature in support of getting this bill passed. I am excited to know over these next 10 years or so, we will be seeing hopefully MANY more of these types of medications, that will save patients billions of dollars and also allow them to have them much more affordable. I wish everyone a good weekend. It is dreary and appears as if we could almost have thunderstorms. The humidity has to be 100% PLUS!!! Insane for sure... from one extreme to the other... and between my own joints and pain, Jim's issues since the wreck, and even my two dogs... I saw them struggling somewhat with "stiffness" and some pain in their joints too. I will "post" more about this bill on my blog and the information on it so you can also do your own research!

HERE IS THE WORDING TO THE TEXAS BILL :

Support HB 751 / SB 542
To Allow Texas Pharmacists to Substitute Interchangeable Biological Products,
Help Remove Barriers to Lower Cost Drugs and Ensure Patient Safety.

What the legislation does:
HB 751 / SB 542 updates the Texas Pharmacy Practice Act.

Provides Texas pharmacists with the ability to dispense safe and less expensive biologic medications to patients, by allowing substitution of an FDA-approved interchangeable biologic for an innovator biologic brand product.

Current Texas law does not allow pharmacists to substitute any biologic drug products; therefore, pharmacists will be required to obtain advanced approval from the prescriber before they are allowed to substitute an FDA-approved interchangeable biologic for a brand name biologic.          HB 751 / SB 542 removes this hurdle.

The current pharmacy practice act has specific rules that must be followed to ensure safe generic substitution of traditional drugs. HB 751 / SB 542 updates these laws to include a similar process to ensure safe biologic substitution. Biosimilars are expected on the market in 2015.

Assures that only FDA-approved “interchangeable” biologic products may be substituted without prior prescriber consent. This is similar to substitution requirements of generic substitution.

Retains the authority of physicians to call for Dispense as Written or DAW. This is identical to the authority they have with generic substitution.

Ensures pharmacist communication with the patient about the substitution, in the same way they are notified about a generic substitution.

Because biologic products differ from generics in complexity and are not identical chemical products, HB 751 / SB 542 ensures there will be transparent communication between pharmacists and prescribing physicians to ensure the patient’s medical record reflects which specific product(s) have been dispensed. This information can be relayed after the prescription is dispensed to alleviate the need to wait for pre-approval, as current law requires.

Why support HB 751 / SB 542:
HB 751 / SB 542 recognizes the growing use of interoperable electronic health records and electronic prescribing records, allowing such systems to be used by a patient’s health care team to communicate regarding a patient’s complete medication history.

HB 751 / SB 542 will streamline the substitution process by allowing pharmacists to substitute an FDA approved interchangeable biologic without first seeking approval.

HB 751 / SB 542 will increase access to lower cost drugs for patients. Biosimilars are forecast to lead to a $44.2 billion reduction in direct spending on brand-name biologics from 2014 to 2024, according to the Rand Corporation.

We are among the Texas patient and provider groups that have studied interchangeable biologic substitution and agree with the principles for safe substitution included in HB 751 / SB 542. Please vote yes!

HERE IS the information from the Arthritis Foundation and some of the other organizations supporting the bill.

FDA APPROVES 1ST "Biosimilar"! Great News!

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm

This is just awesome news! Although this particular one is not related to Autoimmune illness, it is definitely a prosperous beginning to getting "biosimilars" into other types of illnesses, including RA, Sjogren's, Lupus and many of the other 100's of Autoimmune illnesses.

Here is another link that gives you a huge amount of information on Biosimilars. They are NOT a "generic" form of other "Name brand" medications. I am sure many of us are thinking this. But this website below DOES tell all about them, all of the huge non-profits like the AF, IFAA, AARDA, Lupus Foundation and many more that are supporting this effort.

This can mean many more of us that have these illnesses be able to have a more "affordable" type of medication in the near future.

So, take a few moments to look over the website, and also the link above is the news press release for "ZARXIO"....


http://www.biosimsafety.org/pbsamembers/