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Canadian Pharmacare Report Urges Mandatory Substitution

Recommendations by Canada’s advisory council implementing national pharmacare include mandatory generic substitution and also mechanisms of biosimilar substitution.

Regulation Canada Generic Drugs

FDA Approves Amgen And Allergan’s Kanjinti Trastuzumab Biosimilar

Amgen and Allergan’s biosimilar version of Herceptin has been approved by the US Food and Drug Administration.

Biosimilars United States Regulation

Montelukast Sees Fivefold Price Rise In UK

Montelukast 10mg tablets saw their average price rocket up by more than 500% in May 2019, according to the latest figures from WaveData.

United Kingdom Pricing Strategies Market Intelligence
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Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

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Commercial Explore this Topic

Novartis Sees Space For Sandoz But In A Slimmer Streamlined Form

Sandoz has a place within Novartis as a more autonomous unit, the Swiss group’s CEO Vas Narasimhan says. But the generics and biosimilars division will have to sharpen up, aided by a 7% workforce cut.

Strategy Commercial

Three Firms In Race For India’s Bankrupt Orchid Pharma

Three companies are in the race to take over bankrupt Orchid Pharmaceuticals under a new round of bidding being held for the generic drugmaker after a previous takeover deal collapsed.

Deals Strategy

Alkem Grows At Home And Abroad

Alkem said it had a “mixed year”, registering growth in India and internationally despite setbacks that included a weak anti-infectives season and a recent Form 483 from the US Food and Drug Administration.

Sales & Earnings Strategy

Glenmark Invites Investment Into Its Independent APIs Unit

Bringing in a minority investor for its Glenmark Life Sciences raw materials unit and divesting non-core products are among the strategic priorities for Glenmark in its current financial year ending in March 2020.

Strategy Sales & Earnings

Analysts See More Headwinds For India’s Zydus Cadila After Quarterly Earnings Slide

Analysts said more challenges lie ahead for Zydus Cadila that will hobble earnings growth over the next couple of years, after the Indian firm reported a more than 20% slide in quarterly profit.

Strategy Sales & Earnings

Alvogen Expands In CEE With Exeltis Portfolio

Alvogen has struck a deal with Insud’s Exeltis to gain rights to 23 women’s healthcare brands in Russia, Ukraine and Kazakhstan.

Deals Strategy
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Policy & Regulation Explore this Topic

FDA Is Urged To Make All Biosimilar Insulins Interchangeable

As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.

Regulation Biosimilars

Australia Aims To Drive Etanercept Uptake By Broadening Brenzys Listing

Australian authorities are looking to drive uptake of biosimilar etanercept by broadening a reimbursement listing for MSD’s Brenzys, while an advisory committee continues to ponder listings for trastuzumab biosimilars.

Regulation Biosimilars

Biosimilar User Fee Collections Drop Below Estimates, But FDA Is Not Worried

The agency hopes application volume increases, but warns the biosimilar user fee revenue will remain volatile.

Biosimilars Review Pathway

UK Buyers Club Aims For Lower-Cost Cystic Fibrosis Drugs

A buyers club in the UK is planning to import generic versions of Vertex’s cystic fibrosis drugs that are not available on the NHS.  Some commentators think such clubs may become more common.

Europe United Kingdom

Bio Substitution Plan Would Put Germany On ‘Wrong Track’

Plans for substituting biological drugs at pharmacy level that have been passed by Germany’s lower house of parliament threaten to undo the good work done to date in winning trust in biosimilars, local industry association Pro Biosimilars fears.


Germany Biosimilars

ASBM Hits Back At British Columbia Switching Scheme

Originator-backed lobbying group the Alliance for Safe Biologic Medicines has raised concerns over a biosimilar switching policy recently unveiled by the Canadian province of British Columbia.

Regulation Biosimilars
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Latest From Generic Drugs

Oklahoma Judge Wants More Details On Teva’s Opioid Settlement

An Oklahoma judge is withholding approval of the state’s proposed $85m out-of-court opioid settlement with Teva until he gets assurances that it complies with state law.

Legal Issues United States

Novartis Sees Space For Sandoz But In A Slimmer Streamlined Form

Sandoz has a place within Novartis as a more autonomous unit, the Swiss group’s CEO Vas Narasimhan says. But the generics and biosimilars division will have to sharpen up, aided by a 7% workforce cut.

Strategy Commercial

Heritage Clarifies No Guilty Plea In US Settlement

Heritage has clarified that its recent settlement deal with the US Department of Justice over price-fixing allegations did not include the company entering a guilty plea.

Legal Issues Generic Drugs
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Latest From Biosimilars

Novartis Sees Space For Sandoz But In A Slimmer Streamlined Form

Sandoz has a place within Novartis as a more autonomous unit, the Swiss group’s CEO Vas Narasimhan says. But the generics and biosimilars division will have to sharpen up, aided by a 7% workforce cut.

Strategy Commercial

FDA Is Urged To Make All Biosimilar Insulins Interchangeable

As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.

Regulation Biosimilars

Australia Aims To Drive Etanercept Uptake By Broadening Brenzys Listing

Australian authorities are looking to drive uptake of biosimilar etanercept by broadening a reimbursement listing for MSD’s Brenzys, while an advisory committee continues to ponder listings for trastuzumab biosimilars.

Regulation Biosimilars
See All

Latest From Value-Added Medicines

Glenmark Ponders Partners For Omalizumab And Ryaltris Spray

To help fund Phase III clinical trials and US sales and marketing efforts respectively, Glenmark is looking for partners for both its omalizumab biosimilar candidate and its Ryaltris olopatadine and mometasone combination spray.


Respiratory Business Strategies

Private-Equity Firm Buys UK’s Kent Pharma To Start EMEA Generics Push

Acquiring Kent Pharmaceuticals and its antibiotics manufacturing arm Athlone Laboratories is just the start, says private-equity group Duke Street as it eyes expansion into branded generics markets across the Europe, Middle East and Africa region.
M & A United Kingdom

CHMP Maintains Refusal Of TLC's Doxorubicin

The CHMP has confirmed its negative opinion on TLC Biopharmaceuticals’ doxorubicin hybrid. Meanwhile, Accord has received two posaconazole approvals, Zentiva has withdrawn an application for ambrisentan, and the EMA has launched a review of methocarbamol/paracetamol medicines.

Europe Regulation
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