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Biosimilars: Advantages & Challenges

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Introduction

A biosimilar product, as defined by USFDA, is “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” By 2020, the biosimilar market is expected to reach $15 billion booming market, which is thrice the presentmarket(Ragunadhan 2018).Latest additions to this category of drugs are Hadlima(adalimumab-bwwd), Ruxience (rituximab-pvvr), Zirabev (bevacizumab-bvzr) and Kanjinti (trastuzumab-anns), which were approved on June, 2019(USFDA).

Advantages of Biosimilars

Biosimilars are nowadays gaining significant interest due to the advantages associated with it. They are as follows(Ragunadhan 2018)

  1. Reduction in cost:Biosimilar drugs are similar to original drugs, produce equivalent clinical outcomes to that of the original biologics but are less expensive (because their development is not associated with some of the costs borne by pharmaceutical companies in the development of reference agents).The reference drug monopoly is broken when multiple biosimilars are introduced in the market.
  2. Improved patient accessibility: As a number of biosimilar drugs are being launched in the market, and biosimilar drugs are found to reduce the healthcare cost by 40%, more patients can have access tosuch medical innovations at an early stage.
  3. Incentives for innovation:In the wake of expiring patents on reference drugs, innovative and patentable new biologic products may be necessary to maintain a large market share. This will encourage the pharmaceutical companies to invest more to foster innovation in biosimilar drugs.

Challenges of Biosimilars

Despite the benefits, there are few challenges and issues faced by biosimilar market which are as follows(Ragunadhan 2018, Stenger 2018)

Figure 1: Challenges of Biosimilars

Figure 1: Challenges of Biosimilars

  1. Education:Mass education is required in healthcare and pharmaceutical industry/patient and prescriber to enlighten them on the benefits of switching to biosimilars.
  2. Extrapolation issue:“Extrapolation is the process of granting a clinical indication to a medication without its own or new clinical safety and efficacy studies to support that indication”. Guidelines need to be developed to avoid confusion over whether the biosimilar can be used for the off-labelindications also.
  3. Interchangeability issues:Interchangeability issues ariseas the reference product can be substituted with biosimilar. Though guidelines have been published, there is uncertainty prevalent at the prescriber and pharmacist level.
  4. Rare diseases:Orphan drugs are developed for rare diseases. Though biosimilars are developed for the same, but there are many obstacles. It is a challenge to obtain sufficient  non-heterogeneous population for trials. Also, the cost for developing biosimilars to run batch-to-batch variability studiesis high.
  5. Approval process:Common challenges faced by biosimilar manufacturers in processing and packaging are the variability in critical quality attributes between the biosimilar drug and the reference drug which requires manufacturer to provide the FDA with adequate proof of clinical safety.
  6. Post-marketing reporting: As there is no clinical data available, post marketing surveillance is the only tool available to assess the efficacy and safety of biosimilars. However, as the post marketing surveillance process is a herculean task as felt by clinicians, many do not participate in the samedue to time and resource constraints.

Future of biosimilars

There will be a giant leap in biosimilar market in the coming decades(Ragunadhan 2018). As the reference products are nearing their expiry date, the biosimilars market is poised for added growth. Also, it is essential for the professional organizations to provide education and training about biosimilar drugs. This would spread awareness among consumers and healthcare professionals about opportunities and the challenges that these new agents are associated with.

Turacoz Healthcare Solutions, being an active provider of medical communication services, aims to inform people about the advantages and challenges of biosimilars. For any queries, write to us at [email protected]

References

Ragunadhan, M. (2018). Biosimilars: Benefits, Challenges and Futurehttps://blog.kolabtree.com/biosimilars-benefits-challenges-and-future/.
Stenger, M. (2018). “Opportunities, Issues, and Challenges for Biosimilars in Oncology.”  https://www.ascopost.com/issues/july-25-2018/opportunities-issues-and-challenges-for-biosimilars-in-oncology/.
USFDA “Biosimilar Product Information.”

INNOVATIONS IN PEER-REVIEW

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Peer Review is the process of evaluation of manuscripts submitted for scientific publication in journals/books, pre-clinical or clinical study reports, research progress reports etc., by experts or peers with similar competence as manuscript authors. It plays a pivotal role in scholarly publications with objective to ascertain quality, reliability and credibility of the work reported in the manuscripts and reports through qualitative scrutiny. This contributes to the acceptability of scientific work as authentic, rigorous and coherent for the intended purpose. Also, it widens networking opportunities within the scientific fraternity.

Types of Peer Review

  • Single blind review: This is the traditional and most common type of review in which the reviewer’s name is hidden from the author.
  • Double-blind review: In this kind of review, there is anonymity of both the author and the reviewer to each other.
  • Open review: The identity of the author and the reviewer are known to each other and there is more transparent communication during the review process.

Peer-review is a golden practice to improve the quality of publications but comes with its own set of disadvantages and shortcomings. Table 1 details the various featural pros and cons of different types of peer-review.

Table 1 Advantages and Disadvantages of Peer-Reviewing [1]

Ethics of Peer Review

As the reviewing experts are essentially from the same area or field of the study as of the authors of documents under review, some conflict of interests or differences in viewpoints may introduce bias that might come in the way of a fair peer review. For instance, a reviewer may not accept the manuscript/report under review if the author’s hypothesis is different from that of the reviewer. Indeed, many journals take this possibility into account and allow the authors submitting manuscripts to give the name(s) of reviewers to whom the manuscript should not be sent for review in addition to names of reviewers the authors would like to recommend. But then, peer review by reviewers recommended by the authors may also occasionally lead to undeservingly favored evaluation.

To avoid undesirable contentions, it is a prerogative for a peer-reviewer to adhere to ethical guidelines outlined by the Committee of Publication Ethics (COPE), which categorises the ethical responsibility of a peer-review into confidentiality of the data reviewed, objectivity of the review process and diligence towards their competency, following processes, policies and conduct [6].

A few ethical practices that should be incorporated in peer-reviewing are as follows:

  • Maintaining objectivity and diligence in assessing a document
  • Avoiding any favoritism or likewise, negative bias
  • Respecting confidentiality of the manuscript
  • Avoiding giving any personal or derogatory remarks
  • Refraining from disrespectful tone of criticism
  • Maintaining timeliness
  • Adhering to the rationales, norms, policies and specific scope of the journal
  • Promptly reporting any unethical duplication or data fabrication/design
  • Staying discrete from the author during the review process to avoid any unwanted confrontation

Essential Components of Peer-Reviewing

Studies conducted by scientists/experts/professional are rendered into a detailed article or manuscript, a draft of which is then sent to the journal editor. The article is sent by the journal editor to peer reviewers before publication. The reviewers then assess the manuscript and extend their comments focusing on the following aspects:

  • Adequacy of the background information (literature survey) justifying the necessity and purpose of the study reported
  • Appropriateness and adequacy of the materials and methods employed to generate the data
  • Compliance to national and international regulatory requirements [e.g. Good Laboratory/Manufacturing/Clinical Practices (GLP/GMP/GCP), Animal ethics, OECD/ICH/USFDA guidelines etc.]
  • Analysis of data using appropriate (statistical) methods
  • Proper interpretation and discussion of the data/results and the conclusions drawn.
  • Originality of the study
  • Presentation of the manuscript relying on legible and comprehendible language that is grammatically, technically and scientifically correct

Innovations in Peer Review

Any advancement or innovation in a process primarily requires recognition of the prevalent roadblocks. “Necessity is the mother of invention”, Plato’s misattributed proverb reflects the rationale of some compelling advancements that peer-reviewing attributes to the share of challenges it had faced.” Addressing some fundamental conundrums, there are many driven groups across the scientific fraternity who have offer valuable innovative answers.

  • Raising the satisfaction quotient of the author-reviewer-editor trilogy by ‘Volunpeers’

Lack of familiarity with the subject matter causes many reviewers to decline from reviewing. To overcome this challenge, the journal of Molecular biology enabled a Reviewer Recognition Platform, that facilitates reviewers, christened as ‘Volunpeers’ (to represent the rationale of this platform), to register for their area of expertise and receive manuscripts for reviewing according to their preference. The outcome of this platform was impressive! It proudly flaunted a high rate of involvement and satisfaction from both the reviewer and the editor and establishes a faith that peer reviewing indeed has not reached an intimidating stagnancy. Figure 1 indicates the promisingly positive impacts of Volunpeer-ing on various critical aspects [2].

Figure 1: Impact of Peer-Reviewing through the Reviewer Recognition Platform ‘Volunpeer’
  • Expediting the process of review and making it less cumbersome and time‑consuming

The dichotomy of time versus quality lead many to attempt to address long and tiresome process of reviewing. Recently, The Journal of Bone & Joint Surgery (JBJS) has initiated below mentioned tiny steps to upgrade their overall peer-review process [3].

  • Automated and weekly reminder emails to editors
  • Weekly reminder emails for editor queue statistics
  • Monthly emails delineating acceptance rates and transfer rates by editor
  • Shortened deadlines for peer-reviewing
  • Addition of manuscript Xtract in Editorial Manager that reduces manual entry for basic data like manuscript title, author-names, abstract and affiliations
  • Refining the review process by spotting errors and maintaining quality standards of review

The quality of any manuscript proportions directly to the errors established during review and editing process. A keen study conducted on ‘Improving the peer-review process and editorial quality by studying key errors escaping the review and editorial process in top scientific journals [4]. Figure 1 shows the common trend of errors encountered during review.

Figure 1: Proportion and types of errors during review/editing process [4]

The recognition of these error-patterns led to the application of a novel mistake index, independent of the journal’s impact factor. Mistake Index Total (MIT) represented the fraction of corrections published by total number of items published in a year and Mistake Index Paper (MIP) represented the fraction of corrections published by the total number of papers (categorised by articles) published in a year. These were then statistically analysed and applied on scientific journals of diverse disciplines to determine the type, rate of occurrence and severity of errors encountered. It is hence recommended that a detailed guideline based upon MIT and MIP be provided to reviewers, authors and editors, which can help them minimise error redundancy, reduce time-to-correction and reinforce quality of published manuscripts [4].

  • Ensuring recruitment of competent reviewers and providing visibility, value and appreciation for their efforts by R-index

On a more humane level, getting good reviewers and providing visibility, value and appreciation for their efforts stays a huge contributing factor to optimising the quality and efficiency of peer-review. Lack of recognition of time and valuable expertise of the reviewer often is a big dampener for review quality. A simple yet cutting-edge R-index (Reviewer index), has emerged as an essential metric to quantify and credit a scientist’s contribution as a reviewer, regardless of his/her stage of career. Based on the list of reviewers for any particular journal, number of papers reviewed, total number of words against the journal’s impact factor, and eventually fostered by the editor’s feedback on individual review, a score ranging from 0 to 1 is credited to the reviewers. Widely being accepted and implemented, this index is open doors to a wider academic productivity and increased transparency within the scientific community and works reciprocally towards maintaining and enhancing the quality of reviewing [5].

Conclusion

With a fair share of recognition as well as criticism that it comes with, peer-review is undoubtedly an essential component of the publication world. Although an overall positive impact and effectiveness of peer review mechanism to improve upon quality in biomedical journals has been observed in clinical trial and other comparative study publications, it is still difficult to ascertain its tangible impact, considering the aforesaid challenges [7]. Nevertheless, the brighter side shows that the existing peer-review paradigm is inevitably treading towards innovations; profoundly embedded into the process of scientific progress, its indispensable purpose gives reasons enough to boost its operations and we hope to witness more streamlining, transparency, efficiency, robustness and inventive tableaus in its modus operandi.

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances to help researchers stay abreast of important innovations in peer-review in the field of scientific publications. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Reference

  1. https://www.elsevier.com/en-in/reviewers/what-is-peer-review
  2. https://www.elsevier.com/connect/reviewers-update/innovation-in-peer-review-introducing-volunpeers
  3. https://www.csescienceeditor.org/article/new-innovations-in-peer-review/
  4. https://peerj.com/articles/1670/
  5. https://royalsocietypublishing.org/doi/full/10.1098/rsos.140540
  6. https://www.aje.com/arc/ethics-peer-review/
  7. https://www.bmj.com/content/349/bmj.g4145

Here is Everything You Should Know About Cystic Fibrosis

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The month of May is commemorated as Cystic Fibrosis Awareness Month. It aims at raising awareness about cystic fibrosis (CF). Cystic fibrosis foundation (CFF) sponsors this month.

According to estimates, more than 70,000 people globally are affected by cystic fibrosis, but the prevalence of the condition varies globally. The US alone accounts for around 30,000 people living with cystic fibrosis. Around 1000 new cases of cystic fibrosis are diagnosed every year in the US. More than 75% of these cases are of children of age 2 or below. Asia and Africa are thought to be under-diagnosed for CF. Many nations don’t screen for CF in new-borns unlike the US, and the nation registries suffer from lack of data.

What is Cystic Fibrosis (CF)?

CF is a genetic disease that has an impact on lungs and digestive system of human body. Under the influence of this condition, the body produces thick and sticky mucus that can lead to blockage of lungs and obscure pancreas.

In individuals with CF, metamorphosis in the cystic fibrosis transmembrane conductance regulator (CFTR) gene makes the CFTR protein debilitated. When this protein doesn’t function properly, it is incapable of moving chloride- a salt component- to the surface of cell. Without the chloride to bring water to the surface of cell, the mucus in different organs turns thick and sticky.

The mucus blocks the airways and entrap germs such as bacteria, in the lungs, which lead to infections, soreness, respiratory issues and other complications. The people with CF need to be extra cautious and avoid contact with germs.

The thickening of mucus can also lead to infertility in males by clogging the vas deferens or the tube responsible for carrying sperms from testes to urethra.

Symptoms of CF:

Mentioned below are some prominent symptoms of cystic fibrosis:

  • Skin tasting very salty
  • Continual coughing
  • Running out of breath
  • Breathing roughly/heavily
  • Persistent lung infections inclusive of pneumonia or bronchitis
  • Problem with gaining weight despite of heavy diet
  • Infertility in males
  • Greasy and heavy stools
  • Troubles with bowel movements
  • Nasal polyps or slight fleshy growth in the nose

Due to the obstruction in lungs, infections like bronchitis and pneumonia can occur in the patient, leading to growth of pathogens. Blockage in pancreas contribute to malnutrition and poor growth. The risk of developing osteoporosis and diabetes is also associated with it.

Causes of Cystic Fibrosis:

Since CF is a genetic disease, to be affected by it one is required to inherit the mutated gene from both of their parents. The mutated genes are the carriers of codes that produce protein controlling the flow of salt and water on the surface of organs, inclusive of pancreas and lungs.

People suffering from CF struggle with the balance of salt and this leads to more salt and water on the surface of cells and formation of very thick mucus.

Individuals with a single copy of the mutated gene are known as carriers. They do not fall prey to the condition or symptoms of CF. For someone to be affected by CF, both their parents must be the carriers.

If two people are carriers and have a child together, there are:

  • 25% chances that the kid will have CF
  • 50% chances that the kid will be a carrier, but won’t suffer from CF
  • 25% chances that the kid will neither be the carrier and nor suffer from CF

Treatment for CF:

At present, CF is not curable. Certain treatments work on controlling the symptoms and improving quality of life for CF patients. Depending on the kind and intensity of symptoms, the treatments are personalized.

Clearing airway

It is very important for CF patients to reduce the level of mucus in their lungs in order to breathe easily and avoid any lung infections.

Airway Clearance Techniques (ACT) helps individuals with CF to soften their mucus and get rid of it from their lungs. Inhalable medications are effective in reaching the airways and are usually used. The medication can be given through aerosol or through inhalers. These medications help in thinning mucus, killing bacteria and setting off mucus to enhance airway clearance.

Antibiotics act as an essential part of routine care. These can be consumed orally, through injecting and inhalation. Some other medications like azithromycin and ibuprofen are said to protect and enhance lung function and now made a part of standard therapy for CF patients.

CF patients can lower the risk of developing lung infections by taking the below mentioned steps:

  • Washing hands often
  • Avoid smoking
  • Avoid futile contact with people suffering from cold or other contagious diseases
  • Getting a flu injection every year

Other styles of treatment:

Other than the airway clearance technique, there are other types of treatment too.

Implanted devices:

These allow long-term contact with the bloodstream for constant supervision of drugs. These are capable of making the management of CF more powerful and less invasive.

CFTR Modulators:

CFTR (CF Transmembrane Conductance Regulator) modulators are the recent medications developed to focus on the defective CF-causing gene. They help in easing the flow of salt and fluids on the expanse of lungs and weed out the heavy mucus that CF patients generally form in their lungs.

At present, two CFTR modulator brands are certified by FDA (Food and Drug Administration), namely Orkambi and Kalydeco. They’re recommended for children suffering from 10 distinct mutations of the CF-causing gene. Kalydeco might be recommended for kids of age 2 years or more, whereas Orkambi is for kids aged 6.

Remedial measures based on Nutrition:

CF affects the digestive system adversely and the patient suffers from poor nutrient absorption. It is recommended that CF patients should consult their doctor regarding their diet. A nutritionist would assist them in having a control of digestive symptoms.

To balance the digestion of nutrients, a variety of additional supplements like pancreatic enzyme supplements, vitamins or salt might be required along with a specific kind of diet.

CF is responsible flawed growth. To ensure proper development and growth in affected children, a diet rich in calorie and fat, is very essential. It also helps adults in maintaining optimum health. Good nutrition is very crucial for CF patients so that they can be safeguarded against high risk of lung infection.

Cystic fibrosis cannot be cured as of now but with proper care, treatment and diet, the symptoms of it can be controlled. The average life expectancy of CF patients is early 40s. The life expectancy may vary based on the intensity of the symptoms, age of diagnosis and the kind of mutation in gene.

The life expectancy of CF patients has increased significantly in last few years, being around 47 years. There are many patients living well in their 50s or 60s.

Turacoz healthcare solutions, a medical communications firm, believes that appropriate treatment and caution is the key to control currently incurable diseases like cystic fibrosis. Turacoz provides cost-effective medical writing services like regulatory writing, publication writing, advisory board meetings, etc. To know more about Turacoz and to avail the services, drop a mail at [email protected]