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How To Name A Biosimilar: Amgen Persisted With Amjevita Suffix Despite FDA Doubts

Drug Review Profile examines how Amgen persuaded US agency that its preferred distinguishable suffix choice for Amjevita, a biosimilar to AbbVie’s Humira, would not be confused with medical abbreviations or existing trademarks.

Drug Review Profile Biosimilars Regulation

Sandoz Tested Erelzi’s Suffix On Multiple Fronts

Evaluations of potential nonproprietary name suffixes for the US biosimilar to Amgen’s Enbrel included checks on Internet search engines and databases of abbreviations and proprietary names, as well as safety, trademark and phonetic analyses.

Drug Review Profile Biosimilars Regulation

Feel The Quality: Biosimilars Dominate Standards Setting Debate In EU

The quality issues that the European Medicines Agency considers when it evaluates biosimilar medicines became clearer during a recent event held in Strasbourg, France, where delegates also learned more about the role of European Pharmacopoeia monographs in ensuring the quality of biosimilars.

Biosimilars Quality Europe

Medicaid Drug Rebates Will Get Closer Scrutiny From CMS, Verma Pledges

CMS Administrator-nominee Seema Verma promises stronger agency oversight of Medicaid drug rebate program in response to question from Sen. Grassley during Senate confirmation hearing.

Policy Medicaid Pricing Debate
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Policy & Regulation Explore this Topic

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Judge Gorsuch Could Be Pharma Ally In FDA Disputes

Supreme Court nominee's opposition to deference for administrative agencies could help biopharma industry in its battle over off-label communications if the issue ever goes before the court; he also supports securities litigation reform.

BioPharmaceutical Policy Legal Issues

Latest From Regulation

EMA Review Of Non-EU Drugs To Be Made More Useful For African Regulators

The European Medicines Agency is looking into how it can better promote the Article 58 procedure under which it evaluates the quality, safety and efficacy of medicines or vaccines intended for use outside the EU. The procedure has been underutilized by industry to date and the EMA wants to encourage its use, especially for drugs to be used in Sub-Saharan Africa.

Regulation Middle East and Africa

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Regulation Clinical Trials

Amjevita Clinical Development Timeline

Chronicle of the development and FDA review of Amgen’s biosimilar adalimumab-atto (ABP 501).

Drug Review Profile Biosimilars

Latest From Policy

Cost Versus Value: Earnings Calls Spotlight US Pricing Reforms

Pink Sheet has scoured big pharma annual results presentations to gauge the industry's reactions and concerns around the increasingly tough US drug pricing environment and proposed changes to the Affordable Care Act under the new Trump administration.

Pricing Debate Pricing Strategies

Amgen Can't Stop Avastin Biosimilar 'Patent Dance' After Opting In, Genentech Says

Genentech seeks court order requiring Amgen to provide biosimilar manufacturing info so it can evaluate potential infringement; Supreme Court to hear Zarxio case on April 26.

BioPharmaceutical Policy

Turkey Grapples With Spinraza Cost As Patients Seek Access

Families of spinal muscular atrophy patients in Turkey are demanding immediate access to Biogen’s Spinraza following its US approval in December. Its public payer is in discussions over possible reimbursement of the high-priced imported drug but the company is said to have shown no pricing flexibility so far.

Turkey Pricing Debate

Clinical / R&D Explore this Topic

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Latest From Research & Development

Intercept's Revised NASH Trial Improves Prospects

The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

Clinical Trials Research & Development

Catabasis Refutes MRI T2 Biomarker In Duchenne Study

Catabasis says biomarker MRI T2 doesn't work after all in boys with Duchenne's, plans to stick with four-step climb test or 10-meter walk/run test from now on.

Clinical Trials Research & Development

Small Biopharmas Should Be Wary Of Early Results – US FDA Official

Two former Genzyme execs, one of whom now works at CDER, warn small companies to avoid over-emphasizing results from early, uncontrolled trials in their planning and business decision-making.

Research & Development Clinical Trials

Commercial Explore this Topic

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Latest From Commercial

Cost Versus Value: Earnings Calls Spotlight US Pricing Reforms

Pink Sheet has scoured big pharma annual results presentations to gauge the industry's reactions and concerns around the increasingly tough US drug pricing environment and proposed changes to the Affordable Care Act under the new Trump administration.

Pricing Debate Pricing Strategies

J&J Outlines Pricing Transparency Plan, Will Others Follow?

CEO Gorsky describes J&J’s approach to drug pricing and pledges to provide more detail in an annual transparency report. Investor pressure regarding the pricing debate continued during the Novartis earnings call. Value arguments expected to dominate pharma’s message.

Pricing Debate Sales & Earnings

New Policy Fund Reflects Korea’s Commitment To Health Biotech

South Korea's plan to create a policy fund to support new growth engine industries seems to reaffirm the government's unwavering commitment to nurture the biotech and health care sectors despite the ongoing political chaos in the country.

South Korea Financing

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA's Drug Shortage Effort Questioned By GAO

GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.

FDA Life Cycle Management

Biotech Firms Struggle To Replicate Analytical Methods For Commercial Use

The process of transferring analytical methods from research labs to commercial labs is fraught with challenges and biotech manufacturers must pay careful attention to everything in the transfer process, especially for overseas transfers. A diverse toolkit is needed to test these complex molecules. An increasing number of product launches is putting pressure on biotech manufacturers to complete these tech transfers quickly, and industry is receiving little guidance from FDA.

Biologics Manufacturing

BMS Label Issue Adds To China Drug Shortage Woes

While shortages of some drugs in China are not new, a recent case of a patient scrambling to locate a potentially life-saving chemotherapy to complete their treatment has shone new light on the problem, which the government is taking various steps to combat.

Manufacturing Cancer

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Consumer Health Weekly Trademark Review Feb. 14, 2017

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Consumer Trademarks

Ipsen's Latest Consumer Health Play: Growth Or Attracting Suitors?

Less than a month after investing in Italian nutritional supplement maker Akkadeas Pharma, Ipsen acquires five Sanofi OTC drug brands marketed in Europe, including Prontalgine analgesics available in France.

Consumer M & A

Reckitt Expands 'OTC' Business, China Presence With Mead Johnson

Marketing Enfamil and other Mead Johnson formula and nutritional brands, says RB CEO Rakesh Kapoor, is "very much in the core of what consumer health stands for," and also immediately doubles the size of the firm's consumer business.

Consumer China
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