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Canadian Authorities Say Janssen Did Not Choke Competition For Infliximab – But Will Keep Spotlight On Originator Abuse Of Power

In contrast to a US court, the competition authority in Canada has not found evidence that Janssen abused its power in the infliximab market and unlawfully stymied competition from Pfizer’s and Merck’s biosimilars. However, given the relative immaturity of the Canadian biosimilars market, the Competition Bureau said it would continue to watch closely as the market develops.

Biosimilars Canada Market Access

Kox Named As IGBA Secretary General

Industry veteran Suzette Kox has been nominated as secretary general of the International Generic and Biosimilar medicines Association.

Appointments International Regulation

Beximco Expands In US With Eight ANDAs From Sandoz

Beximco has bolstered its position in the US by bumping up its portfolio to 14 approved generics through a deal with Sandoz for a portfolio of eight ANDAs.

Deals United States Generic Drugs
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How to Drive Consistent and Long-Term Growth In the Off-Patent Pharma Arena

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Commercial Explore this Topic

Aceto Files For Bankruptcy As It Offloads Rising And Chemicals Businesses

Struggling US firm Aceto has filed Chapter 11 bankruptcy petitions at the same time as agreeing to divest its chemicals business assets for US$338 million, with plans to also offload its Rising Pharmaceuticals unit.


Strategy Deals

Acino Adds Four To Senior Management Team

Acino has bolstered its senior management team with four appointments, as the Swiss firm aims to strengthen its position as a high-quality pharmaceutical company focusing on emerging markets.

Appointments Leadership

Lupin's US Generics Turn Corner, Upcoming Launches To Fuel Momentum

A recovery in the US, aided by abating pricing pressure and portfolio exits by some large players, augurs well for Indian firm Lupin, but impending new launches including levothyroxine will need to deliver to sustain US momentum.

Commercial Strategy

Dr Reddy's Resolves Legacy Issues At Duvvada After FDA Clears Plant

Dr Reddy’s has been given the all-clear for its Indian formulations manufacturing facility in Duvvada, Visakhapatnam, after the FDA issued an EIR closing out an inspection at the plant that has suffered longstanding quality issues.

India Manufacturing

Alvogen and Dr Reddy’s US Suboxone Rivals Face Off Against Sandoz’ Authorized Generic

Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.

United States Generic Drugs

Teva Barred From Agreeing ‘No-Authorized Generics’ Deals Under Reverse-Payment FTC Settlement

Modifying terms to a 2015 consent decree involving its Cephalon unit, Teva has reached a global settlement agreement with the US Federal Trade Commission that dismisses Teva and its affiliates from three outstanding antitrust cases.

United States Strategy
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Policy & Regulation Explore this Topic

Pfizer Gets Final EU Approval For Biosimilar Bevacizumab

Pfizer has received a pan-European marketing authorization for its Zirabev biosimilar bevacizumab, a rival to Genentech’s Avastin. The nod marks Pfizer’s second European approval for an oncology biosimilar.

Europe Biosimilars

Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

Biosimilars FDA

Canadian Decision On Biological Names Leaves US As The Outlier

Health Canada’s decision to not add a suffix to non-proprietary names for biologics, including biosimilars, has left the US as the only major territory to operate such a convention. The move has been welcomed by the Canadian generics industry.

Canada Biosimilars

FDA Guides On Pathway For Competitive Generic Therapies

Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.

FDA Generic Drugs

E-Leaflets Could Benefit Both European Patients And Industry

By facilitating stock movements by enabling patients to access local-language product information digitally, plans to implement e-leaflets in Europe could also help to alleviate product shortages, the president of Medicines for Europe has suggested.

Europe Regulation

Australia Pushes For Harmonization As ICH Paper Provides Framework

Planned regulatory reforms in Australia would align requirements for generic applications to global standards as well as incentivize filings for complex generics.
Australia Generic Drugs
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Latest From Generic Drugs

Alvogen and Dr Reddy’s US Suboxone Rivals Face Off Against Sandoz’ Authorized Generic

Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.

United States Generic Drugs

Teva’s Schultz Sets Sights On The Horizon While Continuing To Face Headwinds

Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex generics and biologics, even as he continues to cut staff and shut manufacturing sites as part of cost-cutting measures. In the meantime, the firm faces a “trough year” in 2019, and its profitability is continuing to suffer due to impairments including charges linked to its acquisition of Actavis in 2016.

Strategy Sales & Earnings

Mithra Produces First Commercial Myring Batch For Europe

Mithra has produced its first commercial batch of Myring (ethinylestradiol/etonogestrel) for the European market at its CDMO facility in Belgium, soon after striking a 20-year license and supply agreement with ITROM Pharmaceutical Group to sell the combined hormonal contraceptive vaginal ring in the Middle East.

Europe Generic Drugs
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Latest From Biosimilars

Pfizer Gets Final EU Approval For Biosimilar Bevacizumab

Pfizer has received a pan-European marketing authorization for its Zirabev biosimilar bevacizumab, a rival to Genentech’s Avastin. The nod marks Pfizer’s second European approval for an oncology biosimilar.

Europe Biosimilars

Teva’s Schultz Sets Sights On The Horizon While Continuing To Face Headwinds

Teva chief Kåre Schultz has set out his vision for the company to be a world leader in generics, complex generics and biologics, even as he continues to cut staff and shut manufacturing sites as part of cost-cutting measures. In the meantime, the firm faces a “trough year” in 2019, and its profitability is continuing to suffer due to impairments including charges linked to its acquisition of Actavis in 2016.

Strategy Sales & Earnings

Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

Biosimilars FDA
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Latest From Value-Added Medicines

Pfenex One Step Closer To Teriparatide As FDA Accepts NDA

Pfenex maintains it can introduce a follow-on version of Eli Lilly’s Forteo in the fourth quarter of this year, after receiving a target goal date of 7 October 2019 from the FDA.

Value-Added Medicines FDA

CHMP Knocks Back TLC’s Doxorubicin Hybrid

As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.

Europe Regulation

Basaglar Follow-On Insulin Booms For Eli Lilly

Lilly’s Basaglar insulin glargine hybrid is well on its way to becoming a billion-dollar blockbuster.
Metabolic Disorders Sales & Earnings
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