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UNDERSTANDING
BIOSIMILAR DRUGS
Crystal Clear Rx
19753 East Pikes Peak Avenue,
Suite G-103,
Parker,
CO 80138
(303) 955-7827
Understanding Biosimilar Drugs
Drugs called biologics blazed the headlines over the years
because of their potential in fighting serious ailments such as
cancer; these are, however, also famous for their exorbitant price.
The FDA has recently approved the first biosimilar drug that
enables manufacturers to produce low-cost versions of those pricey
drugs, allowing patients to have better access to the medication
without breaking the bank.
What are Biosimilars?
A biosimilar drug is a biological product made of natural
materials that come from microorganisms, animal or human
sources. These products often consist of proteins, sugars, cells or
tissues. The Trastuzumab (Herceptin) drug for breast cancer and
adalimumab (Humira) for arthritis are just some of the biologics
available.
Biosimilars are very similar to FDA-approved biological
drugs called reference products, as they must only have minor
differences in their inactive components to pass government
standards. Biosimilars only get approval if they work the same
way in terms of dosage and strength, in response to symptoms
and conditions. This means that they should have no clinical
differences in terms of effectiveness and safety.
The Importance of Biosimilar Drugs
These drugs are important to consumers because they
help reduce the cost of expensive medications for serious
ailments. The price reduction is not as high as the generic
counterparts of brand-name prescriptions, but is significant
enough to help patients reduce their expenses on drugs to treat
their conditions.
Manufacturers of biosimilar drugs are hard-pressed to
show that there are no significant differences in effectiveness
and safety of their products compared to their original
counterparts. Add that to the fact that is difficult to manufacture
a biosimilar compared to their generic counterparts because of
their complexity.
When a patient gets a prescription for a biosimilar drug, they
must consult with a nurse, doctor or pharmacist to get information
about the results of a clinical trial. These prescriptions are the cheaper
alternative but come with risks, and a patient must be comfortable that
these will get them the same results and effectiveness.
SOURCES:
http://crystalclearrx.com/
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsar
eDevelopedandApproved/ApprovalApplications/TherapeuticBiologicAp
plications/Biosimilars/
http://www.webmd.com/cancer/news/20150310/biosimilar-drugs-faq

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Understanding Biosimilar Drugs

  • 1. UNDERSTANDING BIOSIMILAR DRUGS Crystal Clear Rx 19753 East Pikes Peak Avenue, Suite G-103, Parker, CO 80138 (303) 955-7827
  • 2. Understanding Biosimilar Drugs Drugs called biologics blazed the headlines over the years because of their potential in fighting serious ailments such as cancer; these are, however, also famous for their exorbitant price. The FDA has recently approved the first biosimilar drug that enables manufacturers to produce low-cost versions of those pricey drugs, allowing patients to have better access to the medication without breaking the bank. What are Biosimilars? A biosimilar drug is a biological product made of natural materials that come from microorganisms, animal or human sources. These products often consist of proteins, sugars, cells or tissues. The Trastuzumab (Herceptin) drug for breast cancer and adalimumab (Humira) for arthritis are just some of the biologics available.
  • 3. Biosimilars are very similar to FDA-approved biological drugs called reference products, as they must only have minor differences in their inactive components to pass government standards. Biosimilars only get approval if they work the same way in terms of dosage and strength, in response to symptoms and conditions. This means that they should have no clinical differences in terms of effectiveness and safety. The Importance of Biosimilar Drugs These drugs are important to consumers because they help reduce the cost of expensive medications for serious ailments. The price reduction is not as high as the generic counterparts of brand-name prescriptions, but is significant enough to help patients reduce their expenses on drugs to treat their conditions. Manufacturers of biosimilar drugs are hard-pressed to show that there are no significant differences in effectiveness and safety of their products compared to their original counterparts. Add that to the fact that is difficult to manufacture a biosimilar compared to their generic counterparts because of their complexity.
  • 4. When a patient gets a prescription for a biosimilar drug, they must consult with a nurse, doctor or pharmacist to get information about the results of a clinical trial. These prescriptions are the cheaper alternative but come with risks, and a patient must be comfortable that these will get them the same results and effectiveness. SOURCES: http://crystalclearrx.com/ http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsar eDevelopedandApproved/ApprovalApplications/TherapeuticBiologicAp plications/Biosimilars/ http://www.webmd.com/cancer/news/20150310/biosimilar-drugs-faq