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US FDA draft guidance for biosimilar: First step towards approvals
With the release of draft guidance for biosimilar approval recently, the US FDA has
taken first positive step towards the launch of biosimilars in the US. Though this
guidance does not define the approval pathway, it yet gives an overview of FDA’s
approach to determining biosimilarity for purposes of marketing applications. Some of
it salient features are: 1) a sponsor can use endpoints that are different from those in
the reference product’s clinical trials if they are scientifically justified, 2) potential exists
for the proposed product to be licensed for one or more conditions of use for which the
reference product is licensed and 3) a pediatric assessment is not required for an
interchangeable product.
Drugs worth USD75bn going off‐patent in next 5‐7 years
The biosimilar drugs market is attractive though difficult to enter as developing and
manufacturing biosimilars is more complex than small‐molecule drugs. Moreover,
regulatory pathways often do not exist for many classes of biologics. However, a
pipeline worth USD75bn is getting off‐patent over next five‐seven years, making it far
more attractive.
Draft guidance for biosimilar ‐ First step towards biosimilar launch
The FDA has recently issued the draft guidance for biosimilar approvals which when
finalised will open the door for approvals in the US. This guidance gives an overview of
FDA’s approach to determining biosimilarity for purposes of marketing applications.
Though it does not define the approval pathway immediately, but we consider it as
good news for the US biosimilar industry.
Prominent features of proposed guidance
Significant features of the guidance include: 1) biological product is highly similar to the
reference product notwithstanding minor differences in clinically inactive components
as long as there are no clinically meaningful differences between the biological
product and the reference product in terms of safety, purity and potency b) if the
proposed product is approved for one indication, it can be licensed for one or more
indications for which the reference product is licensed, thus reducing R&D costs for
biosimilar developers and c) a pediatric assessment is not required for interchangeable
products.
Leaders in the game with a large biosimilar portfolio
Sandoz, Teva, Hospira and Merck have the most developed biosimilar pipelines. Most
of these include Monoclonal antibodies (mAbs) which are the largest class of biologics.
Further, Pfizer/Biocon, Lilly and Bioton have developed biosimilar insulin pipeline.
Indian companies such as Dr Reddy, Biocon and Intas Pharma have been working on
biosimilars for quite some time while Dr Reddy’s is the only company in the world to
have launched a generic version of Reditux.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
US FDA draft guidance for biosimilar: First step towards approvals
With the release of draft guidance for biosimilar approval recently, the US FDA has
taken first positive step towards the launch of biosimilars in the US. Though this
guidance does not define the approval pathway, it yet gives an overview of FDA’s
approach to determining biosimilarity for purposes of marketing applications. Some of
it salient features are: 1) a sponsor can use endpoints that are different from those in
the reference product’s clinical trials if they are scientifically justified, 2) potential exists
for the proposed product to be licensed for one or more conditions of use for which the
reference product is licensed and 3) a pediatric assessment is not required for an
interchangeable product.
Drugs worth USD75bn going off‐patent in next 5‐7 years
The biosimilar drugs market is attractive though difficult to enter as developing and
manufacturing biosimilars is more complex than small‐molecule drugs. Moreover,
regulatory pathways often do not exist for many classes of biologics. However, a
pipeline worth USD75bn is getting off‐patent over next five‐seven years, making it far
more attractive.
Draft guidance for biosimilar ‐ First step towards biosimilar launch
The FDA has recently issued the draft guidance for biosimilar approvals which when
finalised will open the door for approvals in the US. This guidance gives an overview of
FDA’s approach to determining biosimilarity for purposes of marketing applications.
Though it does not define the approval pathway immediately, but we consider it as
good news for the US biosimilar industry.
Prominent features of proposed guidance
Significant features of the guidance include: 1) biological product is highly similar to the
reference product notwithstanding minor differences in clinically inactive components
as long as there are no clinically meaningful differences between the biological
product and the reference product in terms of safety, purity and potency b) if the
proposed product is approved for one indication, it can be licensed for one or more
indications for which the reference product is licensed, thus reducing R&D costs for
biosimilar developers and c) a pediatric assessment is not required for interchangeable
products.
Leaders in the game with a large biosimilar portfolio
Sandoz, Teva, Hospira and Merck have the most developed biosimilar pipelines. Most
of these include Monoclonal antibodies (mAbs) which are the largest class of biologics.
Further, Pfizer/Biocon, Lilly and Bioton have developed biosimilar insulin pipeline.
Indian companies such as Dr Reddy, Biocon and Intas Pharma have been working on
biosimilars for quite some time while Dr Reddy’s is the only company in the world to
have launched a generic version of Reditux.
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