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#BIOLOGICS #BIOSIMILARS Awareness Series PART-1/n
Biologics and Biosimilars are two different terms.
Biologics are original drug
Biosimilar is a copy of Biologics.
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Biologics and Biosimilars are two different terms.
Biologics are original drug
Biosimilar is a copy of Biologics.
1/n
#Biologic drugs are complex and made by living organisms and therapeutic proteins, it is impossible to make an exact copy of one. In fact, even different batches made of the same biologic drug aren’t exactly identical.
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2/n
#Biologic drug prices are normally $100000 per patient per year.
#Biologic account for 38% to 40% of all pharmaceutical spending & represented 70% of the growth in US drug spending. Only 2% of people use them
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#Biologic account for 38% to 40% of all pharmaceutical spending & represented 70% of the growth in US drug spending. Only 2% of people use them
3/n
In 2010, US congress passed the #Biologic Price Competition and Innovation Act (BPCIA), modeled loosely on the Hatch-Waxman Act (Generics act). It laid down the path for #biosimilars
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4/n
A #biosimilar drug is a copy version of a biologic drug. But unlike generic drugs (which are exact copies of chemical drugs), #biosimilars are not exact copies.
The FDA requires biosimilars to be made at the same dose and strength as the original biologic product
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The FDA requires biosimilars to be made at the same dose and strength as the original biologic product
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There is no need for the #biosimilars manufacturer to conduct a full set of pre-approval clinical trials for its #biosimilars product. The pre-approval clinical trials are required only for original drug( #biologic)
6/n
6/n
#Biosimilar are still not HOT in USA:
1. Priced very near to biologic
2. Market penetration is not much
3. Delayed market entry due to several litigation& #39;s by originator
4. Originator negotiate formulary exclusivity with payers (No one will tell you this ;-)
7/n
1. Priced very near to biologic
2. Market penetration is not much
3. Delayed market entry due to several litigation& #39;s by originator
4. Originator negotiate formulary exclusivity with payers (No one will tell you this ;-)
7/n
A #biosimilar drug will have the same generic name as the original drug – but it will be followed by a dash and a series of four letters.
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8/n
When #biosimilar sponsors are applying for approval they must measure and present the variations in different lots of the original biologic. FDA has set the rule to do analysis of variability to 10 lots of the original #biologic
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9/n
Still, None of the US #biosimilars has been approved as interchangeable with the original biologic. It means pharmacist can not give you #biosimilar if a #biologic is prescribed
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11/n
