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Legal updates for: BPCIA

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Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not

by McDonnell Boehnen Hulbert & Berghoff LLP on 5/10/2013

...d in the TPP, Senator Hatch reaffirmed his support for this provision of the Biologics Price Competition and Innovation Act (BPCIA), the portion of the Patient Protection and Affordable Care Act that provides an approval pathway for biosimilar biological ... more

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

by Duane Morris LLP on 3/28/2013

...On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ... more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

by McDonnell Boehnen Hulbert & Berghoff LLP on 3/7/2013

...sking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to ... more

Health-Care Reform Creates Large-Dollar Biosimilar Drug Market

by Cozen O'Connor on 11/7/2012

...y pathway for biosimilar versions of biologic medicines. The act created the Biologics Price Competition and Innovation Act (BPCIA), thereby starting the multibillion-dollar, biosimilar drug market of tomorrow and enhancing our future health-care savings.... more

Rep. Eshoo Expresses Views on Abbott's Biosimilars Petition in Letter to FDA

by McDonnell Boehnen Hulbert & Berghoff LLP on 10/26/2012

...as been unable to reach a decision" on a Citizen Petition regarding the Biologics Price Competition and Innovation Act (BPCIA) filed by Abbott Laboratories last April, the same cannot be said of California Representative Anna Eshoo, who sent a letter... more

FDA Continues to Review Abbott Petition on Biosimilars

by McDonnell Boehnen Hulbert & Berghoff LLP on 10/25/2012

Testing And Characterizing Biosimilarity: Will The Hatch-Waxman Safe Harbor Apply?

by Fenwick & West Life Sciences Group on 9/6/2012

... The Biologics Price Competition and Innovation Act ("BPCIA") has not yet led to an approved biosimilar, but one may not be far off. The FDA has conducted meetings with potent... more

PPACA: What’s Next For Life Sciences Companies

by Konstantin Linnik, JD, PhD on 8/24/2012

...ewly established approval pathway for biosimilar products, also known as the Biologics Price Competition and Innovation Act (BPCIA). The number of marketed biologic drugs has been growing steadily, with many multibillion dollar blockbusters already on the... more

The US Health Care Law: What’s Next for Stakeholders

by Konstantin Linnik, JD, PhD on 7/9/2012

... a widely publicized recent health care ruling, the Supreme Court largely upheld the Patient Protection and Affordable Care Act (ACA). The Court determined that the individual mandate is constitutional. However, the Court also found that states with existing Medicaid programs are not required to adopt the law’s expansion to Medicaid... more

Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars

by McDonnell Boehnen Hulbert & Berghoff LLP on 6/29/2012

... as headline-worthy as the individual mandate provision, the survival of the Biologics Price Competition and Innovation Act (BPCIA), which created a new approval pathway in the U.S. for biosimilar products, is still big news to the biotech/pharma world. ... more

Pathway for Follow-on Biologics Survives the Supreme Court

by Morrison & Foerster LLP on 6/29/2012

...Part of the Affordable Care Act—the Biologics Price Competition and Innovation Act (BPCIA)—created a Food and Drug Administration (FDA) approval pathway for “biosimilars,” follow-on versions of bi... more

U.S. Supreme Court Upholds Patient Protection and Affordable Care Act Under Taxation Clause in Nat'l. Fed'n. of Independent Business v. Sebelius

by McDonnell Boehnen Hulbert & Berghoff LLP on 6/28/2012

...r. Receiving far less mainstream news coverage is the ruling's effect on the Biologics Price Competition and Innovation Act (BPCIA), a part of the PPACA which created a new approval pathway in the U.S. for biosimilar products. As a less controversial prov... more

Biosimilar Developers Can Breathe a Sigh of Relief

by Dechert LLP on 6/28/2012

...With this morning’s Supreme Court affirmance of the bulk of the Affordable Care Act, the specter that the BPCIA framework for biosimilar introduction could be dismantled is no longer a concern.... more

Will Thursday Be the End of Biosimilars?

by Dechert LLP on 6/26/2012

...revious post, there is a real possibility that the Court will strike down the entire Affordable Care Act, which includes the BPCIA authorizing approval of biosimilars in the U.S. ... more

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